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Artificial intelligence technologies are being increasingly relied upon in the redirected here healthcare domain, buy viagra usa particularly when it comes to decision support, precision medicine, and the improvement of the quality of care. Regarding primary care specifically, AI also buy viagra usa represents an opportunity to assist with electronic health record documentation. A new study published in the Journal of American Medical Informatics Association this week shows that, although AI documentation assistants (or digital scribes) offer great potential in the primary care setting, they will need to be supervised by a human until strong evidence is available for their autonomous potential.

In workshops with primary buy viagra usa care doctors, wrote researchers from the Australian Institute of Health Innovation, "There was consensus that consultations of the future would increasingly involve more automated and AI-supported systems. However, there were differing views on how this human-AI collaboration would work, what roles doctors and AI would take, and what tasks could be delegated to AI." HIMSS20 Digital Learn on-demand, earn credit, find products and solutions. Get Started buy viagra usa >>.

WHY IT MATTERS Researchers worked with primary care doctors who use EHRs regularly for documentation purposes to understand their views on future AI documentation assistants. They identified three major themes that emerged from the buy viagra usa discussions. Professional autonomy, human-AI collaboration and new models of care.

First, the buy viagra usa doctors emphasized the importance of their ability to care for patients in their own way with the abilities AI technology provided."If they [patients] think that we're just getting suggestions from a computer, then maybe they can just get suggestions from a computer. I think it becomes more difficult to convince them that our recommendations are more valuable than what they can pick up on the internet," said one physician. They noted the need for a bottom-up approach to technology development, with a focus on delivering clear buy viagra usa benefits to practice and workflow, and expressed fears around potential legal complications that could stem from working with an AI assistant.With regard to human-AI collaboration, doctors expressed a variety of viewpoints about what tasks could be delegated to AI.

Many believed that an AI system could assist with tasks such as documentation, referrals and other paperwork. Most said that buy viagra usa AI systems would lack empathy. "GPs voiced several concerns, including some potential biases in patient data and system design, the time needed to fix the errors and train the system, challenges of dealing with complex cases, and the auditing of AI," wrote the researchers.

However, doctors also discussed how AI could help with buy viagra usa emerging models of primary care, including preconsultation, mobile health and telehealth. THE LARGER TREND The question of reducing EHR-related clinician burnout has loomed large, with vendors and researchers trying to pinpoint major causes – and, in turn, potential solutions. AI has been raised as one such solution, with several major EHR buy viagra usa vendors offering plans for incorporating the technology into their workflows.

But human input remains vital, as the new JAMIA study and other research has noted. AI could "bring back meaning and purpose in the practice of medicine while buy viagra usa providing new levels of efficiency and accuracy," wrote Stanford researchers in a 2017 Journal of the American Medical Association study. But, they continued, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care."ON THE RECORD"AI documentation assistants will likely ...

Be integral to the future primary buy viagra usa care consultations. However, these technologies will still need to be supervised by a human until strong evidence for reliable autonomous performance is available. Therefore, different human-AI collaboration models will need to be designed and evaluated to ensure patient safety, quality of care, doctor safety, and doctor autonomy," wrote the buy viagra usa Australian Institute for Health Innovation researchers.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication.Konica Minolta Healthcare buy viagra usa Americas will pay $500,000 to settle a whistleblower case that alleged its Viztek electronic health record subsidiary had falsified data for certification tests.WHY IT MATTERSIn the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program."To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta.

(a) falsely attested to InfoGard that their software met the certification criteria buy viagra usa. (b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria. And (c) caused their users to falsely attest to buy viagra usa using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite its inability to meet ONC's certification criteria.The flaws in Viztek's software "not only rendered the system unreliable and unable to meet meaningful use standards, but the flaws also created a risk to patient health and safety.

Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."THE LARGER TRENDThis is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in 2017 for $155 million.More buy viagra usa recently, similar complaints were lodged against companies such as Practice Fusion and Greenway Health. They settled with DOJ for $145 million and $57 million, respectively."We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S.

Attorney for the District buy viagra usa of Vermont Christina Nolan after the Greenway case this past year. "EHR companies should consider themselves on notice."ON THE RECORD"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent certification must be performed and obtained through a reliable, measurable process.""Filing a qui tam lawsuit is a powerful and effective way buy viagra usa to report problems with EHR software purchased with federal funds and get the problems fixed when they are ignored," said Luke Diamond, an associate at Phillips &.

Cohen. "The False Claims Act protects whistleblowers from job retaliation and offers rewards if the government recovers funds as a result of the qui tam case.""Our client was concerned buy viagra usa about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to inform the government about what she had witnessed," said Colette Matzzie, a partner and whistleblower attorney with Phillips &. Cohen, which brought the case.

"Ensuring that EHR software meets all governmental requirements is important to safeguard both patient care and federal funds."The Arc Madison Cortland in Oneida, New York, knows that there is buy viagra usa a lack of providers that specialize in the intellectual/developmental disability field. Making the problem worse, not so many that understand dual diagnosis.THE PROBLEMWith COVID-19 minimizing the ability for individuals to receive face-to-face services with their providers, many patients are resorting to emergency department visits.Additionally, The Arc is in a rural area requiring travel to see a provider, and there is a lack buy viagra usa of providers in the field. The population itself is underserved, with a lack of transportation to get to appointments.

Without the ability to institute telemedicine as a solution to these problems, the population buy viagra usa supported by The Arc would have seen a lengthy (permanent?. ) pause for needed medical services.PROPOSALThe Arc this year received funding from the FCC to help provide telehealth services.“With this funding we can further treat patients, reduce crisis and allow for social distancing, which is imperative to our vulnerable population,” said Jackie Fahey, director of clinic services at The Arc Madison Cortland. €œWe could provide ongoing services to the individuals we serve to ensure there are no unnecessary emergency buy viagra usa department visits.

This places less of a strain on our local emergency departments and unneeded additional costs.”With the purchase of tablets and headsets and telehealth services from vendor Doxy.me, The Arc was able to still provide medical care to its population of people with an I/DD. Additionally, eliminating emergency department visits also eliminates their exposure to buy viagra usa COVID-19 and eases the burden of the ED providers who are overburdened right now.MARKETPLACEThere are many vendors of telemedicine technology and services on the health IT market today. Healthcare IT News recently compiled a comprehensive list of these vendors with detailed descriptions.

To read this special report, click here.MEETING THE CHALLENGE“When all of our locations were closed abruptly in the middle of March due to the COVID-19 pandemic, we needed to determine a way to quickly and easily implement a telehealth solution so that we were able to still support the individuals that we serve during the crisis, especially when buy viagra usa many were under strict quarantine protocols for a variety of reasons,” Fahey explained.“We signed up immediately for the Doxy.me telehealth platform as it was a user-friendly platform that is HIPAA-compliant. The feature we liked about Doxy.me was that it is web-based, so nothing had to be downloaded and it could easily be used on a laptop, tablet or smartphone.”The Arc rolled out the technology initially with its mental health providers, who offer psychiatry/medication monitoring services, social work counseling and mental health counseling. More than half the organization’s enrollment is enrolled in buy viagra usa one or all of these three services, so it was able to continue providing services to a large number of enrolled individuals.“We then began to roll the telehealth services out to nutrition, speech therapy, physical therapy and occupational therapy caseloads if individuals were appropriate to receive the service through telehealth,” Fahey said.RESULTSThe first success metric The Arc has been able to achieve with the technology is maintaining its utilization for mental health services.

When everything was running normal prior to COVID-19, The Arc’s mental health services made up about 25% of the services it provided on a monthly basis. With the implementation of telehealth services during the COVID-19 pandemic, the organization was able to achieve 20% of the services provided on a monthly basis.This has shown to staff that they have been able to still serve and respond to the needs of their buy viagra usa psychiatry, social work and mental health counseling patients with minimal issues by implementing the telehealth technology.“The second success metric we have been able to achieve with the technology is we have been able to continue to receive referrals for our services and enroll new individuals into the services they need if the services are able to be completed via telehealth,” she said. €œBetween April, May and June, we have enrolled 16 new individuals into ongoing clinic services, which is right on par for our normal enrollment average per month.”USING FCC AWARD FUNDSThe Arc Madison Cortland was awarded $49,455 by the FCC earlier this year for laptop computers and headsets to provide remote consultations and treatment during the COVID-19 pandemic for psychological services, counseling, and occupational and physical therapy for people with developmental and other disabilities.“With the funds, we purchased headsets and tablets to allow the people we support to have access to medical appointments, along with physical therapy, occupational therapy and psychology appointments remotely,” Fahey explained.

€œThe technology enables us to continue to provide these services at a time when the people we support are unable to leave for traditional in-person appointments.“Because these are such uncertain times, and a time frame for when we may return to ‘normalcy’ is unknown, the technology allows us to continue delivering medical support without the concern of a pause in those services.”Twitter buy viagra usa. @SiwickiHealthITEmail the writer. Bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.HIMSSCast host Jonah Comstock convenes a panel of HIMSS Media editors – HITN Senior Editor Kat Jercich, MobiHealthNews Associate Editor Dave Muoio and HFN Associate Editor Jeff Lagasse – to discuss recent delivery slowdowns at the Post Office and how they have and haven't affected healthcare stakeholders, including startups and patients buy viagra usa.

The team also looks into the broader trend of the politicization of traditionally apolitical government agencies and how that could affect public faith in COVID-19 treatments or vaccines.More about this episode:USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than othersMail delays may affect medication supply for nearly 1 in 4 Americans over 50Postmaster General Louis DeJoy's full testimony (C-SPAN)The Package Coalition homepageThe Trump administration this week asked the U.S. Supreme Court buy viagra usa to reverse a lower court ruling that allowed for mail-order and telemedicine abortion during the COVID-19 crisis. U.S.

Food and Drug Administration regulations require mifepristone, which is used in medication abortion, to be dispensed at a clinic, hospital or buy viagra usa medical office. In June, U.S. District Judge buy viagra usa for the District of Maryland Theodore Chuang blocked the requirements during the pandemic, finding them to be a "substantial obstacle." Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation.

In 2017, a New England Journal of Medicine article argued against the FDA regulations for mifepristone given the drug's safety record. WHY buy viagra usa IT MATTERS Acting Solicitor General Jeffrey B. Wall applied for a stay of Chuang's injunction on Wednesday as the case makes its way through the lower courts, arguing that the regulations do not represent an undue burden.

"The safety requirements here concern only medication buy viagra usa abortions using Mifeprex, which is approved for use only during the first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall. Reproductive rights groups spoke out against the move, noting that people buy viagra usa of color are disproportionately affected both by abortion restrictions and by the COVID-19 pandemic.

"Black, Brown, Indigenous people and people of color are already dying/getting sick at disproportionate rates from COVID-19," said All Above All* on Twitter. "The Trump-Pence admin is trying to make this worse by buy viagra usa asking SCOTUS to require people face unnecessary risk just to get abortion care." "The FDA’s in-person requirements on mifepristone subject patients to unnecessary exposure to a deadly virus, and two federal courts have already rejected the Trump administration’s argument. Forcing patients to travel to a health center to access the safe, effective medication they need especially hurts people of color and people with low-incomes, who already face more barriers to care," said Planned Parenthood Federation of America President and CEO Alexis McGill-Johnson in a statement.THE LARGER TREND The COVID-19 pandemic has exacerbated many existing barriers to care, including for reproductive health services.

"We’ve seen the undue burden and hardship these restrictions create during COVID-19, especially in buy viagra usa communities hit hardest by the pandemic," said Skye Perryman, chief legal officer at the American College of Obstetricians and Gynecologists, a co-plaintiff in the telemedicine case, to Healthcare IT News. In response to the July ruling, some abortion providers reportedly moved to delivering mifepristone by mail. Still, others faced state laws that restricted the provision of abortion via telemedicine.And as buy viagra usa Dr.

Jacquelyn Yeh from Physicians from Reproductive Health pointed out in July, telemedicine itself involves hurdles such as broadband access and privacy concerns. It remains to be seen whether the Supreme Court will grant buy viagra usa the Trump administration's request. ON THE RECORD "As COVID-19 ravages Black, Latino, Indigenous, and other communities of color across the country, the Trump administration should be aiming to keep us healthy – not moving forward with an agenda to endanger people who seek abortion," said McGill-Johnson.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication..

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The Coronavirus Outbreak 12h ago Judge upholds Cuomo’s restrictions on religious services in hot spots. 13h ago Latino and Black Americans are still dying in disproportionately high numbers, the C.D.C. Says. 16h ago Keuka College sends students home because of coronavirus outbreak.

See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 coronavirus cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the pandemic. Among them. The Purgatory Correctional Center in Hurricane, Utah, with 166 infections.

The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, infections at the jail make up about a quarter of all known virus cases in the county. Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases. In the past two months, Mr.

Krogue said, the jail released 29 people who were considered actively infected.Infections at the jail make up about a quarter of Cascade County’s known virus cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks. The Cascade County Detention Center sits along a highway at the edge of town. Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring. Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said.

€œIs there concern?. Sure, there’s concern. But is there overreaction?. No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the virus, said Mr.

Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer. The county has seen 1,261 cases and six deaths during the pandemic, a Times database shows. Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants.

Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said. €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said. Three inmates shared cells designed for two. At night, men slept on thin blue pads in every available space.

On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the virus. He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?. € he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr.

Hawley said, he and other prisoners protested the way the virus was being handled by refusing to leave their living areas and by blocking new inmates from entering. Everyone was ultimately tested, Mr. Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said. €œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties.

Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care. Seven inmates, as well as some staff members, were hospitalized. No one from the jail has died from the virus, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr. Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children.

He remains healthy but says he fears bringing the virus home. The virus has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr. Krogue said. €œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb.

Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Food and Drug Administration, HHS. Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE).

This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. The announcement of the guidances is published in the Federal Register on October 16, 2020.

The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. You may submit either electronic or written comments on Agency guidances at any time as follows. Electronic Submissions Submit electronic comments in the following way. Federal eRulemaking Portal.

Https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process.

Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows. Mail/Hand Delivery/Courier (for written/paper submissions).

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the name of the guidance document that the comments address and the docket number for the guidance (see table 1).

Received comments will be placed in the docket(s) and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500. Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total.

One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in Start Printed Page 65821its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.

For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of these guidances to the address noted in table 1. Send two self-addressed adhesive labels to assist that office in processing your requests.

See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances. Start Further Info Kimberly Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357.

End Further Info End Preamble Start Supplemental Information I. Background On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.[] On March 13, 2020, President Donald J.

Trump declared that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.[] In the Federal Register of March 25, 2020 (the March 25, 2020, notice) (available at https://www.govinfo.gov/​content/​pkg/​FR-2020-03-25/​pdf/​2020-06222.pdf), FDA announced procedures for making available FDA guidances related to the COVID-19 PHE. These procedures, which operate within FDA's established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders. The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID-19 PHE, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidances. Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

371(h)(1)(C) and 21 CFR 10.115(g)(2) (§ 10.115(g)(2))). The guidances are available at FDA's web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled “Search for FDA Guidance Documents” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID-19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID-19-related guidances. Table 1—Guidances Related to the COVID-19 Public Health EmergencyDocket No.CenterTitle of guidanceContact information to request single copiesFDA-2020-D-1136CDERManufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (August 2020)druginfo@fda.hhs.gov. Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1136CDERResuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (September 2020)druginfo@fda.hhs.gov.

Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1106CDERFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (March 2020) (Updated September 2020)Clinicaltrialconduct-COVID19@fda.hhs.gov. Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request. Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)). These guidances are being issued consistent with FDA's good guidance practices regulation (§ 10.115).

The Start Printed Page 65822guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III.

Paperwork Reduction Act of 1995 CDER Guidances The guidances listed in the table below refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for these guidances. However, these previously approved collections of information are subject to review by OMB under the PRA.

The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table. Table 2—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance title referenced in COVID-19 guidanceOMB control No(s).Guidance for Industry. Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency21 CFR 210 and 211, 21 CFR 514.80, 21 CFR 600—Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients —Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. €”Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.

€”Reporting and Mitigating Animal Drug Shortages During the COVID-19 Public Health Emergency.0910-0001, 0910-0032, 0910-0139, 0910-0338, 0910-0669, 0910-0675, 0910-0759, 0910-0806.Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency. Questions and Answers21 CFR 314.50. 314.95, 314.125, 314.127. 601.2 and 601.20—Prioritization of the Review of Original ANDAs, Amendments, and Supplements —Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.0910-0001, 0910-0014, 0910-0338, 0910-0045, 0910-0139, 0910-0759. —Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA). —Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. —Changes to an Approved Application.

Biological Products. —Changes to an Approved NDA or ANDA. Questions and Answers. —Changes to an Approved NDA or ANDA. —CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. —Changes to an Approved Application. Biological Products. Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. —CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. —Chemistry, Manufacturing, and Controls Changes to an Approved Application.

Certain Biological Products. —Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. —SUPAC-IR. Questions and Answers about SUPAC-IR Guidance. —Nonsterile Semisolid Dosage Forms.

Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls. In Vitro Release Testing and In Vivo Bioequivalence Documentation. —SUPAC-MR. Modified Release Solid Oral Dosage Forms.

Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.Start Printed Page 65823 —SUPAC. Manufacturing Equipment Addendum.

The guidance listed in the table below refers to previously approved FDA collections of information. Therefore, clearance by OMB under the PRA is not required for this guidance. However, these collections of information are subject to review by OMB under the PRA. The previously approved collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the table below.

This guidance also contains a collection of information not approved under a current collection. This collection of information has been granted a PHE waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/​public-health-emergency-declaration-pra-waivers. Table 3—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance referenced in COVID-19 guidanceOMB control No(s).Collection covered by PHE PRA waiverGuidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (Updated September 21, 2020)21 CFR part 11, 21 CFR part 50, 21 CFR part 56, 21 CFR part 312, 21 CFR part 314, 21 CFR part 320, 21 CFR part 601, 21 CFR part 812Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Pediatric Study Plans. Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Design.

Pregnant Women. Scientific and Ethical Considerations for Inclusion in Clinical Trials. Part 11, Electronic Records. Electronic Signatures Scope and Application.0910-0001, 0910-0014, 0910-0130, 0910-0303, 0910-0338, 0910-0119, 0910-0581, 0910-0733, 0910-0078Submission by investigators of informed consent forms to third parties. Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11—Questions and Answers.

Safety Reporting Requirements for INDs and BA/BE Studies. Adverse Event Reporting to IRBs—Improving Human Subject Protection. Use of Electronic Informed Consent In Clinical Investigations. E6(R2) Good Clinical Practice.

Integrated Addendum to ICH E6(R1). Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Requests for Feedback and Meetings for Medical Device Submissions.

The Q-Submission Program. IV. Electronic Access Persons with access to the internet may obtain COVID-19-related guidances at. Start Signature Start Printed Page 65824 Dated.

October 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc.

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The Coronavirus Outbreak 12h ago Judge upholds Cuomo’s restrictions on religious services in hot spots. 13h ago Latino and Black Americans are still dying in disproportionately high numbers, the C.D.C. Says. 16h ago Keuka College sends students home because of coronavirus outbreak.

See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 coronavirus cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the pandemic. Among them. The Purgatory Correctional Center in Hurricane, Utah, with 166 infections.

The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, infections at the jail make up about a quarter of all known virus cases in the county. Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases. In the past two months, Mr.

Krogue said, the jail released 29 people who were considered actively infected.Infections at the jail make up about a quarter of Cascade County’s known virus cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks. The Cascade County Detention Center sits along a highway at the edge of town. Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring. Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said.

€œIs there concern?. Sure, there’s concern. But is there overreaction?. No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the virus, said Mr.

Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer. The county has seen 1,261 cases and six deaths during the pandemic, a Times database shows. Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants.

Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said. €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said. Three inmates shared cells designed for two. At night, men slept on thin blue pads in every available space.

On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the virus. He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?. € he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr.

Hawley said, he and other prisoners protested the way the virus was being handled by refusing to leave their living areas and by blocking new inmates from entering. Everyone was ultimately tested, Mr. Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said. €œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties.

Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care. Seven inmates, as well as some staff members, were hospitalized. No one from the jail has died from the virus, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr. Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children.

He remains healthy but says he fears bringing the virus home. The virus has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr. Krogue said. €œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb.

Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Food and Drug Administration, HHS. Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE).

This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. The announcement of the guidances is published in the Federal Register on October 16, 2020.

The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. You may submit either electronic or written comments on Agency guidances at any time as follows. Electronic Submissions Submit electronic comments in the following way. Federal eRulemaking Portal.

Https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process.

Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows. Mail/Hand Delivery/Courier (for written/paper submissions).

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the name of the guidance document that the comments address and the docket number for the guidance (see table 1).

Received comments will be placed in the docket(s) and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500. Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total.

One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in Start Printed Page 65821its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.

For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of these guidances to the address noted in table 1. Send two self-addressed adhesive labels to assist that office in processing your requests.

See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances. Start Further Info Kimberly Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357.

End Further Info End Preamble Start Supplemental Information I. Background On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.[] On March 13, 2020, President Donald J.

Trump declared that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.[] In the Federal Register of March 25, 2020 (the March 25, 2020, notice) (available at https://www.govinfo.gov/​content/​pkg/​FR-2020-03-25/​pdf/​2020-06222.pdf), FDA announced procedures for making available FDA guidances related to the COVID-19 PHE. These procedures, which operate within FDA's established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders. The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID-19 PHE, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidances. Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

371(h)(1)(C) and 21 CFR 10.115(g)(2) (§ 10.115(g)(2))). The guidances are available at FDA's web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled “Search for FDA Guidance Documents” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID-19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID-19-related guidances. Table 1—Guidances Related to the COVID-19 Public Health EmergencyDocket No.CenterTitle of guidanceContact information to request single copiesFDA-2020-D-1136CDERManufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (August 2020)druginfo@fda.hhs.gov. Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1136CDERResuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (September 2020)druginfo@fda.hhs.gov.

Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1106CDERFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (March 2020) (Updated September 2020)Clinicaltrialconduct-COVID19@fda.hhs.gov. Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request. Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)). These guidances are being issued consistent with FDA's good guidance practices regulation (§ 10.115).

The Start Printed Page 65822guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III.

Paperwork Reduction Act of 1995 CDER Guidances The guidances listed in the table below refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for these guidances. However, these previously approved collections of information are subject to review by OMB under the PRA.

The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table. Table 2—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance title referenced in COVID-19 guidanceOMB control No(s).Guidance for Industry. Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency21 CFR 210 and 211, 21 CFR 514.80, 21 CFR 600—Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients —Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. €”Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.

€”Reporting and Mitigating Animal Drug Shortages During the COVID-19 Public Health Emergency.0910-0001, 0910-0032, 0910-0139, 0910-0338, 0910-0669, 0910-0675, 0910-0759, 0910-0806.Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency. Questions and Answers21 CFR 314.50. 314.95, 314.125, 314.127. 601.2 and 601.20—Prioritization of the Review of Original ANDAs, Amendments, and Supplements —Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.0910-0001, 0910-0014, 0910-0338, 0910-0045, 0910-0139, 0910-0759. —Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA). —Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. —Changes to an Approved Application.

Biological Products. —Changes to an Approved NDA or ANDA. Questions and Answers. —Changes to an Approved NDA or ANDA. —CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. —Changes to an Approved Application. Biological Products. Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. —CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. —Chemistry, Manufacturing, and Controls Changes to an Approved Application.

Certain Biological Products. —Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. —SUPAC-IR. Questions and Answers about SUPAC-IR Guidance. —Nonsterile Semisolid Dosage Forms.

Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls. In Vitro Release Testing and In Vivo Bioequivalence Documentation. —SUPAC-MR. Modified Release Solid Oral Dosage Forms.

Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.Start Printed Page 65823 —SUPAC. Manufacturing Equipment Addendum.

The guidance listed in the table below refers to previously approved FDA collections of information. Therefore, clearance by OMB under the PRA is not required for this guidance. However, these collections of information are subject to review by OMB under the PRA. The previously approved collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the table below.

This guidance also contains a collection of information not approved under a current collection. This collection of information has been granted a PHE waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/​public-health-emergency-declaration-pra-waivers. Table 3—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance referenced in COVID-19 guidanceOMB control No(s).Collection covered by PHE PRA waiverGuidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (Updated September 21, 2020)21 CFR part 11, 21 CFR part 50, 21 CFR part 56, 21 CFR part 312, 21 CFR part 314, 21 CFR part 320, 21 CFR part 601, 21 CFR part 812Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Pediatric Study Plans. Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Design.

Pregnant Women. Scientific and Ethical Considerations for Inclusion in Clinical Trials. Part 11, Electronic Records. Electronic Signatures Scope and Application.0910-0001, 0910-0014, 0910-0130, 0910-0303, 0910-0338, 0910-0119, 0910-0581, 0910-0733, 0910-0078Submission by investigators of informed consent forms to third parties. Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11—Questions and Answers.

Safety Reporting Requirements for INDs and BA/BE Studies. Adverse Event Reporting to IRBs—Improving Human Subject Protection. Use of Electronic Informed Consent In Clinical Investigations. E6(R2) Good Clinical Practice.

Integrated Addendum to ICH E6(R1). Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Requests for Feedback and Meetings for Medical Device Submissions.

The Q-Submission Program. IV. Electronic Access Persons with access to the internet may obtain COVID-19-related guidances at. Start Signature Start Printed Page 65824 Dated.

October 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc.

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If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Viagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Viagra does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

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Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a study that has determined the role that a critical protein plays in the development of http://cz.keimfarben.de/where-to-buy-female-viagra/ hair pink viagra cells. These hair pink viagra cells are vital for hearing. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain.

Ronna Hertzano, MD, PhD, Associate Professor in the Department of Otorhinolaryngology Head and Neck Surgery at UMSOM and Maggie Matern, PhD, a postdoctoral fellow at Stanford pink viagra University, demonstrated that the protein, called GFI1, may be critical for determining whether an embryonic hair cell matures into a functional adult hair cell or becomes a different cell that functions more like a nerve cell or neuron.The study was published in the journal Development, and was conducted by physician-scientists and researchers at the UMSOM Department of Otorhinolaryngology Head and Neck Surgery and the UMSOM Institute for Genome Sciences (IGS), in collaboration with researchers at the Sackler School of Medicine at Tel Aviv University in Israel.Hearing relies on the proper functioning of specialized cells within the inner ear called hair cells. When the hair cells do not develop properly or are damaged by environmental stresses like loud noise, it results in a loss of hearing function.In the United States, the prevalence of hearing loss doubles with every 10-year increase in age, affecting about half of all adults in their 70s and about 80 percent of those who are over age 85. Researchers have been focusing on describing the developmental pink viagra steps that lead to a functional hair cell, in order to potentially generate new hair cells when old ones are damaged.Hair cells in the inner earTo conduct her latest study, Dr.

Hertzano and her team utilized cutting-edge methods to study gene expression in the hair cells of genetically modified newborn mice that did not produce GFI1. They demonstrated that, in the absence pink viagra of this vital protein, embryonic hair cells failed to progress in their development to become fully functional adult cells. In fact, the genes expressed by these cells indicated that they were likely to develop into neuron-like cells."Our findings explain why GFI1 is critical to enable embryonic cells to progress into functioning adult hair cells," said Dr.

Hertzano. "These data also explain the importance of GFI1 in experimental protocols to regenerate hair cells from stem cells. These regenerative methods have the potential of being used for patients who have experienced hearing loss due to age or environmental factors like exposure to loud noise."Dr.

Hertzano first became interested in GFI1 while completing her M.D., Ph.D. At Tel Aviv University. As part of her dissertation, she discovered that the hearing loss resulting from mutations in another protein called POU4F3 appeared to largely result from a loss of GFI1 in the hair cells.

Since then, she has been conducting studies to discover the role of GFI1 and other proteins in hearing. Other research groups in the field are now testing these proteins to determine whether they can be used as a "cocktail" to regenerate lost hair cells and restore hearing."Hearing research has been going through a Renaissance period, not only from advances in genomics and methodology, but also thanks to its uniquely collaborative nature among researchers," said Dr. Herzano.The new study was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) which is part of the National Institutes of Health (NIH).

It was also funded by the Binational Scientific Foundation (BSF)."This is an exciting new finding that underscores the importance of basic research to lay the foundation for future clinical innovations," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. And Akiko K.

Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "Identifying the complex pathways that lead to normal hearing could prove to be the key for reversing hearing loss in millions of Americans." Story Source. Materials provided by University of Maryland School of Medicine.

Note. Content may be edited for style and length.Researchers at Indiana University School of Medicine are learning more about how a person's genes play a role in the possibility they'll suffer from alcoholic cirrhosis with the discovery of a gene that could make the disease less likely.Alcoholic cirrhosis can happen after years of drinking too much alcohol. According to the researchers, discovering more about this illness couldn't come at a more important time."Based on U.S.

Data, alcohol-associated liver disease is on the rise in terms of the prevalence and incidents and it is happening more often in younger patients," said Suthat Liangpunsakul, MD, professor of medicine, dean's scholar in medical research for the Department of Medicine Division of Gastroenterology and Hepatology, and one of the principal investigators of the study. "There's a real public health problem involving the consumption of alcohol and people starting to drink at a younger age."The team describes their findings in a new paper published in Hepatology. The GenomALC Consortium was funded by the National Institutes on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institute of Health (NIH).

This genome-wide association study began several years ago and is one of the largest studies related to alcoholic cirrhosis ever performed. DNA samples were taken from over 1,700 patients from sites in the United States, several countries in Europe and Australia and sent to IU School of Medicine where the team performed the DNA isolation for genome analysis. The patients were divided into two groups -- one made up of heavy drinkers that never had a history of alcohol-induced liver injury or liver disease and a second group of heavy drinkers who did have alcoholic cirrhosis."Our key finding is a gene called Fas Associated Factor Family Member 2, or FAF2," said Tae-Hwi Schwantes-An, PhD, assistant research professor of medical and molecular genetics and the lead author of the study.

"There's this convergence of findings now that are pointing to the genes involved in lipid droplet organization pathway, and that seems to be one of the biological reasonings of why certain people get liver disease and why certain people do not."The researchers are anticipating to study this gene more closely and looking at its relationship to other, previously-discovered genes that can make a person more likely to develop alcoholic cirrhosis."We know for a fact those genes are linked together in a biological process, so the logical next step is to study how the changes in these genes alter the function of that process, whether it's less efficient in one group of people, or maybe it's inhibited in some way," Schwantes-An said. "We don't know exactly what the biological underpinning of that is, but now we have a pretty well-defined target where we can look at these variants and see how they relate to alcoholic cirrhosis."As their research continues, the team hopes to eventually find a way to identify this genetic factor in patients with the goal of helping them prevent alcoholic cirrhosis in the future or developing targeted therapies that can help individuals in a more personalized way. Story Source.

Materials provided by Indiana University School of Medicine. Original written by Christina Griffiths. Note.

Content may be edited for style and length.Penn Medicine researchers have found that middle-aged individuals -- those born in the late 1960s and the 1970s -- may be in a perpetual state of H3N2 influenza virus susceptibility because their antibodies bind to H3N2 viruses but fail to prevent infections, according to a new study led by Scott Hensley, PhD, an associate professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania. The paper was published today in Nature Communications."We found that different aged individuals have different H3N2 flu virus antibody specificities," Hensley said. "Our studies show that early childhood infections can leave lifelong immunological imprints that affect how individuals respond to antigenically distinct viral strains later in life."Most humans are infected with influenza viruses by three to four years of age, and these initial childhood infections can elicit strong, long lasting memory immune responses.

H3N2 influenza viruses began circulating in humans in 1968 and have evolved substantially over the past 51 years. Therefore, an individual's birth year largely predicts which specific type of H3N2 virus they first encountered in childhood.Researchers completed a serological survey -- a blood test that measures antibody levels -- using serum samples collected in the summer months prior to the 2017-2018 season from 140 children (ages one to 17) and 212 adults (ages 18 to 90). They first measured the differences in antibody reactivity to various strains of H3N2, and then measured for neutralizing and non-neutralizing antibodies.

Neutralizing antibodies can prevent viral infections, whereas non-neutralizing antibodies can only help after an infection takes place. Samples from children aged three to ten years old had the highest levels of neutralizing antibodies against contemporary H3N2 viruses, while most middle-aged samples had antibodies that could bind to these viruses but these antibodies could not prevent viral infections.Hensley said his team's findings are consistent with a concept known as "original antigenic sin" (OAS), originally proposed by Tom Francis, Jr. In 1960.

"Most individuals born in the late 1960s and 1970s were immunologically imprinted with H3N2 viruses that are very different compared to contemporary H3N2 viruses. Upon infection with recent H3N2 viruses, these individuals tend to produce antibodies against regions that are conserved with older H3N2 strains and these types of antibodies typically do not prevent viral infections."According to the research team, it is possible that the presence of high levels of non-neutralizing antibodies in middle-aged adults has contributed to the continued persistence of H3N2 viruses in the human population. Their findings might also relate to the unusual age distribution of H3N2 infections during the 2017-2018 season, in which H3N2 activity in middle-aged and older adults peaked earlier compared to children and young adults.The researchers say that it will be important to continually complete http://cz.keimfarben.de/walmart-viagra-price-2020/ large serological surveys in different aged individuals, including donors from populations with different vaccination rates.

A better understanding of immunity within the population and within individuals will likely lead to improved models that are better able to predict the evolutionary trajectories of different influenza virus strains."Large serological studies can shed light on why the effectiveness of flu vaccines varies in individuals with different immune histories, while also identifying barriers that need to be overcome in order to design better vaccines that are able to elicit protective responses in all age groups," said Sigrid Gouma, PhD, a postdoctoral researcher of Microbiology and first author on the paper.Other Penn authors include Madison Weirick and Megan E. Gumina. Additional authors include Angela Branche, David J.

Topham, Emily T. Martin, Arnold S. Monto, and Sarah Cobey.This work was supported by the National Institute of Allergy and Infectious Diseases (1R01AI113047, S.E.H..

1R01AI108686, S.E.H.. 1R01AI097150, A.S.M.. CEIRS HHSN272201400005C, S.E.H., S.C., E.T.M., A.S.M.

A.B., D.J.T.) and Center for Disease Control (U01IP000474, A.S.M.). Scott E. Hensley holds an Investigators in the Pathogenesis of Infectious Disease Awards from the Burroughs Wellcome Fund.Males and females share the vast majority of their genomes.

Only a sprinkling of genes, located on the so-called X and Y sex chromosomes, differ between the sexes. Nevertheless, the activities of our genes -- their expression in cells and tissues -- generate profound distinctions between males and females.Not only do the sexes differ in outward appearance, their differentially expressed genes strongly affect the risk, incidence, prevalence, severity and age-of-onset of many diseases, including cancer, autoimmune disorders, cardiovascular disease and neurological afflictions.Researchers have observed sex-associated differences in gene expression across a range of tissues including liver, heart, and brain. Nevertheless, such tissue-specific sex differences remain poorly understood.

Most traits that display variance between males and females appear to result from differences in the expression of autosomal genes common to both sexes, rather than through expression of sex chromosome genes or sex hormones.A better understanding of these sex-associated disparities in the behavior of our genes could lead to improved diagnoses and treatments for a range of human illnesses.In a new paper in the PERSPECTIVES section of the journal Science, Melissa Wilson reviews current research into patterns of sex differences in gene expression across the genome, and highlights sampling biases in the human populations included in such studies."One of the most striking things about this comprehensive study of sex differences," Wilson said, "is that while aggregate differences span the genome and contribute to biases in human health, each individual gene varies tremendously between people."Wilson is a researcher in the Biodesign Center for Mechanisms in Evolution, the Center for Evolution and Medicine, and ASU's School of Life Sciences. advertisement A decade ago, an ambitious undertaking, known as the Genotype-Tissue Expression (GTEx) consortium began to investigate the effects DNA variation on gene expression across the range of human tissues. Recent findings, appearing in the Science issue under review, indicate that sex-linked disparities in gene expression are far more pervasive than once assumed, with more than a third of all genes displaying sex-biased expression in at least one tissue.

(The new research highlighted in Wilson's PERSPECTIVES piece describes gene regulatory differences between the sexes in every tissue under study.)Sex-linked differences in gene expression are shared across mammals, though their relative roles in disease susceptibility remain speculative. Natural selection likely guided the development of many of these attributes. For example, the rise of placental mammals some 90 million years ago may have led to differences in immune function between males and females.Such sex-based distinctions arising in the distant past have left their imprint on current mammals, including humans, expressed in higher rates of autoimmune disorders in females and increased cancer rates in males.Despite their critical importance for understanding disease prevalence and severity, sex differences in gene expression have only recently received serious attention in the research community.

Wilson and others suggest that much historical genetic research, using primarily white male subjects in mid-life, have yielded an incomplete picture.Such studies often fail to account for sex differences in the design and analysis of experiments, rendering a distorted view of sex-based disease variance, often leading to one-size-fits-all approaches to diagnosis and treatment. The authors therefore advise researchers to be more careful about generalizations based on existing databases of genetic information, including GTEx.A more holistic approach is emerging, as researchers investigate the full panoply of effects related to male and female gene expression across a broader range of human variation. Story Source.

Materials provided by Arizona State University. Original written by Richard Harth. Note.

Content may be edited for style and length.Researchers at Yale have identified a possible treatment for Duchenne muscular dystrophy (DMD), a rare genetic disease for which there is currently no cure or treatment, by targeting an enzyme that had been considered "undruggable." The finding appears in the Aug. 25 edition of Science Signaling.DMD is the most common form of muscular dystrophy, a disease that leads to progressive weakness and eventual loss of the skeletal and heart muscles. It occurs in 16 of 100,000 male births in the U.S.

People with the disease exhibit clumsiness and weakness in early childhood and typically need wheelchairs by the time they reach their teens. The average life expectancy is 26.While earlier research had revealed the crucial role played by an enzyme called MKP5 in the development of DMD, making it a promising target for possible treatment, scientists for decades had been unable to disrupt this family of enzymes, known as protein tyrosine phosphatases, at the enzymes' "active" site where chemical reactions occur.In the new study, Anton Bennett, the Dorys McConnell Duberg Professor of Pharmacology and professor of comparative medicine, and his team screened over 162,000 compounds. They identified one molecular compound that blocked the enzyme's activity by binding to a previously undiscovered allosteric site -- a spot near the enzyme's active site."There have been many attempts to design inhibitors for this family of enzymes, but those compounds have failed to produce the right properties," Bennett said.

"Until now, the family of enzymes has been considered 'undruggable.'"By targeting the allosteric site of MKP5 instead, he said, "We discovered an excellent starting point for drug development that circumvented the earlier problems."The researchers tested their compound in muscle cells and found that it successfully inhibited MKP5 activity, suggesting a promising new therapeutic strategy for treating DMD.The research was supported by a National Institutes of Health grant through the National Institute of Arthritis and Musculoskeletal and Skin Diseases, as well as by the Blavatnik Fund for Innovation at Yale, which annually presents awards to support the most promising life science discoveries from Yale faculty.Bennett said that the Blavatnik funding, which is administered by the Yale Office of Cooperative Research, was critical in moving the research forward. "It resulted in a license with a major pharmaceutical company," he said, "and we hope they will rapidly move forward with the development of the new treatment."The finding has implications well beyond muscular dystrophy, he added. The researchers have demonstrated that the MKP5 enzyme is broadly implicated in fibrosis, or the buildup of scar tissue, a condition that contributes to nearly one-third of natural deaths worldwide."Fibrosis is involved in the end-stage death of many tissues, including liver, lung, and muscle," Bennett said.

"We believe this enzyme could be a target more broadly for fibrotic tissue disease."The research team from Yale included Naftali Kaminski, the Boehringer-Ingelheim Professor of Internal Medicine and chief of pulmonary, critical care and sleep medicine. Jonathan Ellman, the Eugene Higgins Professor of Chemistry and professor of pharmacology. Karen Anderson, professor of pharmacology and of molecular biophysics and biochemistry.

Elias Lolis, professor of pharmacology. Zachary Gannam, a graduate student in pharmacology. Kisuk Min, a postdoctoral fellow.

Shanelle Shillingford, a graduate student in chemistry. Lei Zhang, a research associate in pharmacology. And the Yale Center for Molecular Discovery.

Story Source. Materials provided by Yale University. Original written by Brita Belli.

Note. Content may be edited for style and length..

Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a http://cz.keimfarben.de/walmart-viagra-price-2020/ study that has buy viagra usa determined the role that a critical protein plays in the development of hair cells. These hair buy viagra usa cells are vital for hearing. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain.

Ronna Hertzano, MD, PhD, Associate Professor in the Department of Otorhinolaryngology Head and Neck Surgery at UMSOM and Maggie Matern, PhD, a postdoctoral fellow at Stanford University, demonstrated that the protein, called GFI1, may be critical for determining buy viagra usa whether an embryonic hair cell matures into a functional adult hair cell or becomes a different cell that functions more like a nerve cell or neuron.The study was published in the journal Development, and was conducted by physician-scientists and researchers at the UMSOM Department of Otorhinolaryngology Head and Neck Surgery and the UMSOM Institute for Genome Sciences (IGS), in collaboration with researchers at the Sackler School of Medicine at Tel Aviv University in Israel.Hearing relies on the proper functioning of specialized cells within the inner ear called hair cells. When the hair cells do not develop properly or are damaged by environmental stresses like loud noise, it results in a loss of hearing function.In the United States, the prevalence of hearing loss doubles with every 10-year increase in age, affecting about half of all adults in their 70s and about 80 percent of those who are over age 85. Researchers have been focusing on describing the developmental steps that lead buy viagra usa to a functional hair cell, in order to potentially generate new hair cells when old ones are damaged.Hair cells in the inner earTo conduct her latest study, Dr.

Hertzano and her team utilized cutting-edge methods to study gene expression in the hair cells of genetically modified newborn mice that did not produce GFI1. They demonstrated that, in buy viagra usa the absence of this vital protein, embryonic hair cells failed to progress in their development to become fully functional adult cells. In fact, the genes expressed by these cells indicated that they were likely to develop into neuron-like cells."Our findings explain why GFI1 is critical to enable embryonic cells to progress into functioning adult hair cells," said Dr.

Hertzano. "These data also explain the importance of GFI1 in experimental protocols to regenerate hair cells from stem cells. These regenerative methods have the potential of being used for patients who have experienced hearing loss due to age or environmental factors like exposure to loud noise."Dr.

Hertzano first became interested in GFI1 while completing her M.D., Ph.D. At Tel Aviv University. As part of her dissertation, she discovered that the hearing loss resulting from mutations in another protein called POU4F3 appeared to largely result from a loss of GFI1 in the hair cells.

Since then, she has been conducting studies to discover the role of GFI1 and other proteins in hearing. Other research groups in the field are now testing these proteins to determine whether they can be used as a "cocktail" to regenerate lost hair cells and restore hearing."Hearing research has been going through a Renaissance period, not only from advances in genomics and methodology, but also thanks to its uniquely collaborative nature among researchers," said Dr. Herzano.The new study was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) which is part of the National Institutes of Health (NIH).

It was also funded by the Binational Scientific Foundation (BSF)."This is an exciting new finding that underscores the importance of basic research to lay the foundation for future clinical innovations," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. And Akiko K.

Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "Identifying the complex pathways that lead to normal hearing could prove to be the key for reversing hearing loss in millions of Americans." Story Source. Materials provided by University of Maryland School of Medicine.

Note. Content may be edited for style and length.Researchers at Indiana University School of Medicine are learning more about how a person's genes play a role in the possibility they'll suffer from alcoholic cirrhosis with the discovery of a gene that could make the disease less likely.Alcoholic cirrhosis can happen after years of drinking too much alcohol. According to the researchers, discovering more about this illness couldn't come at a more important time."Based on U.S.

Data, alcohol-associated liver disease is on the rise in terms of the prevalence and incidents and it is happening more often in younger patients," said Suthat Liangpunsakul, MD, professor of medicine, dean's scholar in medical research for the Department of Medicine Division of Gastroenterology and Hepatology, and one of the principal investigators of the study. "There's a real public health problem involving the consumption of alcohol and people starting to drink at a younger age."The team describes their findings in a new paper published in Hepatology. The GenomALC Consortium was funded by the National Institutes on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institute of Health (NIH).

This genome-wide association study began several years ago and is one of the largest studies related to alcoholic cirrhosis ever performed. DNA samples were taken from over 1,700 patients from sites in the United States, several countries in Europe and Australia and sent to IU School of Medicine where the team performed the DNA isolation for genome analysis. The patients were divided into two groups -- one made up of heavy drinkers that never had a history of alcohol-induced liver injury or liver disease and a second group of heavy drinkers who did have alcoholic cirrhosis."Our key finding is a gene called Fas Associated Factor Family Member 2, or FAF2," said Tae-Hwi Schwantes-An, PhD, assistant research professor of medical and molecular genetics and the lead author of the study.

"There's this convergence of findings now that are pointing to the genes involved in lipid droplet organization pathway, and that seems to be one of the biological reasonings of why certain people get liver disease and why certain people do not."The researchers are anticipating to study this gene more closely and looking at its relationship to other, previously-discovered genes that can make a person more likely to develop alcoholic cirrhosis."We know for a fact those genes are linked together in a biological process, so the logical next step is to study how the changes in these genes alter the function of that process, whether it's less efficient in one group of people, or maybe it's inhibited in some way," Schwantes-An said. "We don't know exactly what the biological underpinning of that is, but now we have a pretty well-defined target where we can look at these variants and see how they relate to alcoholic cirrhosis."As their research continues, the team hopes to eventually find a way to identify this genetic factor in patients with the goal of helping them prevent alcoholic cirrhosis in the future or developing targeted therapies that can help individuals in a more personalized way. Story Source.

Materials provided by Indiana University School of Medicine. Original written by Christina Griffiths. Note.

Content may be edited for style and length.Penn Medicine researchers have found that middle-aged individuals -- those born in the late 1960s and the 1970s -- may be in a perpetual state of H3N2 influenza virus susceptibility because their antibodies bind to H3N2 viruses but fail to prevent infections, according to a new study led by Scott Hensley, PhD, an associate professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania. The paper was published today in Nature Communications."We found that different aged individuals have different H3N2 flu virus antibody specificities," Hensley said. "Our studies show that early childhood infections can leave lifelong immunological imprints that affect how individuals respond to antigenically distinct viral strains later in life."Most humans are infected with influenza viruses by three to four years of age, and these initial childhood infections can elicit strong, long lasting memory immune responses.

H3N2 influenza viruses began circulating in humans in 1968 and have evolved substantially over the past 51 years. Therefore, an individual's birth year largely predicts which specific type of H3N2 virus they first encountered in childhood.Researchers completed a serological survey -- a blood test that measures antibody levels -- using serum samples collected in the summer months prior to the 2017-2018 season from 140 children (ages one to 17) and 212 adults (ages 18 to 90). They first measured the differences in antibody reactivity to various strains of H3N2, and then measured for neutralizing and non-neutralizing antibodies.

Neutralizing antibodies can prevent viral infections, whereas non-neutralizing antibodies can only help after an infection takes place. Samples from children aged three to ten years old had the highest levels of neutralizing antibodies against contemporary H3N2 viruses, while most middle-aged samples had antibodies that could bind to these viruses but these antibodies could not prevent viral infections.Hensley said his team's findings are consistent with a concept known as "original antigenic sin" (OAS), originally proposed by Tom Francis, Jr. In 1960.

"Most individuals born in the late 1960s and 1970s were immunologically imprinted with H3N2 viruses that are very different compared to contemporary H3N2 viruses. Upon infection with recent H3N2 viruses, these individuals tend to produce antibodies against regions that are conserved with older H3N2 strains and these types of antibodies typically do not prevent viral infections."According to the research team, it is possible that the presence of high levels of non-neutralizing antibodies in middle-aged adults has contributed to the continued persistence of H3N2 viruses in the human population. Their findings might also relate to the unusual age distribution of H3N2 infections during the 2017-2018 season, in which H3N2 activity in middle-aged and older adults peaked earlier compared to children and young adults.The researchers say that it will be important to continually complete large serological surveys in different aged individuals, including donors from populations with different vaccination rates.

A better understanding of immunity within the population and within individuals will likely lead to improved models that are better able to predict the evolutionary trajectories of different influenza virus strains."Large serological studies can shed light on why the effectiveness of flu vaccines varies in individuals with different immune histories, while also identifying barriers that need to be overcome in order to design better vaccines that are able to elicit protective responses in all age groups," said Sigrid Gouma, PhD, a postdoctoral researcher of Microbiology and first author on the paper.Other Penn authors include Madison Weirick and Megan E. Gumina. Additional authors include Angela Branche, David J.

Topham, Emily T. Martin, Arnold S. Monto, and Sarah Cobey.This work was supported by the National Institute of Allergy and Infectious Diseases (1R01AI113047, S.E.H..

1R01AI108686, S.E.H.. 1R01AI097150, A.S.M.. CEIRS HHSN272201400005C, S.E.H., S.C., E.T.M., A.S.M.

A.B., D.J.T.) and Center for Disease Control (U01IP000474, A.S.M.). Scott E. Hensley holds an Investigators in the Pathogenesis of Infectious Disease Awards from the Burroughs Wellcome Fund.Males and females share the vast majority of their genomes.

Only a sprinkling of genes, located on the so-called X and Y sex chromosomes, differ between the sexes. Nevertheless, the activities of our genes -- their expression in cells and tissues -- generate profound distinctions between males and females.Not only do the sexes differ in outward appearance, their differentially expressed genes strongly affect the risk, incidence, prevalence, severity and age-of-onset of many diseases, including cancer, autoimmune disorders, cardiovascular disease and neurological afflictions.Researchers have observed sex-associated differences in gene expression across a range of tissues including liver, heart, and brain. Nevertheless, such tissue-specific sex differences remain poorly understood.

Most traits that display variance between males and females appear to result from differences in the expression of autosomal genes common to both sexes, rather than through expression of sex chromosome genes or sex hormones.A better understanding of these sex-associated disparities in the behavior of our genes could lead to improved diagnoses and treatments for a range of human illnesses.In a new paper in the PERSPECTIVES section of the journal Science, Melissa Wilson reviews current research into patterns of sex differences in gene expression across the genome, and highlights sampling biases in the human populations included in such studies."One of the most striking things about this comprehensive study of sex differences," Wilson said, "is that while aggregate differences span the genome and contribute to biases in human health, each individual gene varies tremendously between people."Wilson is a researcher in the Biodesign Center for Mechanisms in Evolution, the Center for Evolution and Medicine, and ASU's School of Life Sciences. advertisement A decade ago, an ambitious undertaking, known as the Genotype-Tissue Expression (GTEx) consortium began to investigate the effects DNA variation on gene expression across the range of human tissues. Recent findings, appearing in the Science issue under review, indicate that sex-linked disparities in gene expression are far more pervasive than once assumed, with more than a third of all genes displaying sex-biased expression in at least one tissue.

(The new research highlighted in Wilson's PERSPECTIVES piece describes gene regulatory differences between the sexes in every tissue under study.)Sex-linked differences in gene expression are shared across mammals, though their relative roles in disease susceptibility remain speculative. Natural selection likely guided the development of many of these attributes. For example, the rise of placental mammals some 90 million years ago may have led to differences in immune function between males and females.Such sex-based distinctions arising in the distant past have left their imprint on current mammals, including humans, expressed in higher rates of autoimmune disorders in females and increased cancer rates in males.Despite their critical importance for understanding disease prevalence and severity, sex differences in gene expression have only recently received serious attention in the research community.

Wilson and others suggest that much historical genetic research, using primarily white male subjects in mid-life, have yielded an incomplete picture.Such studies often fail to account for sex differences in the design and analysis of experiments, rendering a distorted view of sex-based disease variance, often leading to one-size-fits-all approaches to diagnosis and treatment. The authors therefore advise researchers to be more careful about generalizations based on existing databases of genetic information, including GTEx.A more holistic approach is emerging, as researchers investigate the full panoply of effects related to male and female gene expression across a broader range of human variation. Story Source.

Materials provided by Arizona State University. Original written by Richard Harth. Note.

Content may be edited for style and length.Researchers at Yale have identified a possible treatment for Duchenne muscular dystrophy (DMD), a rare genetic disease for which there is currently no cure or treatment, by targeting an enzyme that had been considered "undruggable." The finding appears in the Aug. 25 edition of Science Signaling.DMD is the most common form of muscular dystrophy, a disease that leads to progressive weakness and eventual loss of the skeletal and heart muscles. It occurs in 16 of 100,000 male births in the U.S.

People with the disease exhibit clumsiness and weakness in early childhood and typically need wheelchairs by the time they reach their teens. The average life expectancy is 26.While earlier research had revealed the crucial role played by an enzyme called MKP5 in the development of DMD, making it a promising target for possible treatment, scientists for decades had been unable to disrupt this family of enzymes, known as protein tyrosine phosphatases, at the enzymes' "active" site where chemical reactions occur.In the new study, Anton Bennett, the Dorys McConnell Duberg Professor of Pharmacology and professor of comparative medicine, and his team screened over 162,000 compounds. They identified one molecular compound that blocked the enzyme's activity by binding to a previously undiscovered allosteric site -- a spot near the enzyme's active site."There have been many attempts to design inhibitors for this family of enzymes, but those compounds have failed to produce the right properties," Bennett said.

"Until now, the family of enzymes has been considered 'undruggable.'"By targeting the allosteric site of MKP5 instead, he said, "We discovered an excellent starting point for drug development that circumvented the earlier problems."The researchers tested their compound in muscle cells and found that it successfully inhibited MKP5 activity, suggesting a promising new therapeutic strategy for treating DMD.The research was supported by a National Institutes of Health grant through the National Institute of Arthritis and Musculoskeletal and Skin Diseases, as well as by the Blavatnik Fund for Innovation at Yale, which annually presents awards to support the most promising life science discoveries from Yale faculty.Bennett said that the Blavatnik funding, which is administered by the Yale Office of Cooperative Research, was critical in moving the research forward. "It resulted in a license with a major pharmaceutical company," he said, "and we hope they will rapidly move forward with the development of the new treatment."The finding has implications well beyond muscular dystrophy, he added. The researchers have demonstrated that the MKP5 enzyme is broadly implicated in fibrosis, or the buildup of scar tissue, a condition that contributes to nearly one-third of natural deaths worldwide."Fibrosis is involved in the end-stage death of many tissues, including liver, lung, and muscle," Bennett said.

"We believe this enzyme could be a target more broadly for fibrotic tissue disease."The research team from Yale included Naftali Kaminski, the Boehringer-Ingelheim Professor of Internal Medicine and chief of pulmonary, critical care and sleep medicine. Jonathan Ellman, the Eugene Higgins Professor of Chemistry and professor of pharmacology. Karen Anderson, professor of pharmacology and of molecular biophysics and biochemistry.

Elias Lolis, professor of pharmacology. Zachary Gannam, a graduate student in pharmacology. Kisuk Min, a postdoctoral fellow.

Shanelle Shillingford, a graduate student in chemistry. Lei Zhang, a research associate in pharmacology. And the Yale Center for Molecular Discovery.

Story Source. Materials provided by Yale University. Original written by Brita Belli.

Note. Content may be edited for style and length..

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While there’s been plenty of grim news to buy viagra usa come out of the COVID-19 pandemic, there have also been a few heartwarming trends, too. For one, since March animal shelters throughout the U.S. Have seen a significant spike in animal adoptions and buy viagra usa foster care placements — particularly for dogs.

As people settled into quarantine, shelters across the country began reporting an unprecedented amount of requests by people wanting to adopt dogs. In addition, Kitty Block, CEO and president of the Humane Society of the United States, says that in March and April the number of nationwide foster animal placements increased by 40 to 50 percent from 2019. During one week in March alone, placements soared by 790 buy viagra usa percent compared to the same time period last year.

This boom in adoptions and foster placements stems from an obvious cause. For people stuck at home, buy viagra usa the idea of animal companionship is now more appealing than ever. And studies from experts in human-animal interaction have shown that dogs can have a measurably positive effect on your mental health.     Pets for Stress Relief Even limited interaction with dogs and other animals can have a beneficial impact on humans.

Last year, Patricia Pendry, a human development researcher at Washington State University, led a study that tested college animal visitation programs, where domesticated animals are brought on campus during exam weeks to provide stress relief for students. Researchers divided 249 participants into four groups, who were then buy viagra usa given 10 minutes to interact with dogs and cats to varying degrees. One group was allowed to pet the animals, another watched dogs receive pets and a third was simply shown images.

The participants’ saliva was tested for cortisol, a buy viagra usa stress hormone, before and after. The researchers found that cortisol levels significantly decreased among students who directly pet dogs during that 10-minute interval.   Pendry says that her study did not differentiate how dogs impacted stress relief compared to cats, so it’s unclear if dogs decrease cortisol levels more effectively than their feline friends. She suspects that depends on a person’s personal preference, but notes that the stress relief benefits of dog-human interactions tend to be more visible due to the animal’s energetic behavior.  “Dogs tend to be animals who very actively seek out interaction with people,” says Pendry.

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Over the course of four weeks, 33 veterans took part in weekly 30-minute dog walks. The scientists measured psychological and buy viagra usa physiological stress indicators, like cortisol levels and heart rate variability, among the participants both before and after the strolls. A control group walked with another human instead of a dog.     The study found that walking with dogs tended to decrease signs of PTSD — particularly variability in heart rate — in veterans with severe symptoms more than walking with another human.

Krause-Parello says that the study is preliminary, but it does suggest animals can help relieve the effects of PTSD. Plus, that animal companionship can have measurable buy viagra usa benefits for veterans. She adds that the study was set up so veterans could adopt a shelter job and have their adoption fee covered.

Afterwards, several of them choose to do so.            “We had the veterans pick buy viagra usa the dog’s names out of the hat,” says Krause-Parello, who also directs Canines Providing Assistance to Wounded Warriors, a research initiative that examines how dogs influence the health and well-being of veterans. “We didn’t want anyone to get too attached to one of the animals in case they got adopted. But one of them picked a name out of the hat, walked the dog, and immediately came back and put in an application to adopt that dog.

That was really fun.” Pendry notes that it’s important to consider how these interactions buy viagra usa impact both the human and the animal. Animal-human interplay can be mutually beneficial, helping improve the health and well-being of the animal while also providing mental health benefits for the human.   “When we’re studying marital functioning, for example, you wouldn’t just ask one spouse, you ideally take both perspectives,” Pendry says. “That’s the same with human-animal interactions — we have to consider the well-being and functioning of the animal, because there’s a lot to be gained for them, as well.”       .

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