| Coronavirus Disease 2019 (COVID-19) updates | Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: Bookmark www.fda.gov/coronavirus for the latest. | |  | | | FDA issues alert regarding SARS-CoV-2 viral mutation to health care providers and clinical laboratory staff FDA is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taking additional actions to ensure authorized tests remain accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. The FDA believes the risk that these mutations will impact overall testing accuracy is low. (January 8, 2020) Related links:  FDA Publishes Report on Focus Areas of Regulatory Science FDA conducts regulatory science research, which is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of certain FDA-regulated products. It also enables the FDA to understand and assess risk, prepare for and respond to public health emergencies and help ensure the safety of products used by patients. FDA published the report, 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS), to communicate the importance and impact of the FDA's scientific research and activities. (January 11, 2021) Related links: | | Emergency Use Authorization (EUA) updates | Moderna COVID-19 Vaccine FAQs FDA posted a new web page, Moderna COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA review when deciding whether to authorize the vaccine for emergency use, how well the vaccine prevents COVID-19, and more. (January 8, 2021) Diagnostic test EUAs As of today, 316 tests and sample collection devices are authorized by FDA under EUAs. These include 235 molecular tests and sample collection devices, 68 antibody tests, and 13 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 1 antigen prescription at-home test, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics | |  | | | Events - Today! January 13, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host an additional webinar in this series on January 27, 2021.
- January 14, 2021: CDER Compliance Conference - Participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. CE credit available.
- New! January 19-20, 2021: Microphysiological Systems: Bridging Human and Animal Research - A Workshop, hosted by the National Academies of Sciences, Engineering, and Medicine - Several FDA speakers will present.
- February 2-3, 2021: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials (remote only) - The Duke-Margolis Center for Health Policy, under a cooperative agreement with FDA, is convening this public webinar to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant women in clinical trials.
- May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year's keynote speaker is NIAID Director Anthony Fauci, MD.
| | Information for industry Antimicrobial resistance (AMR) - FDA's Center for Veterinary Medicine published a concept paper to obtain early input from the public on a potential framework for how animal drug sponsors could voluntarily make changes to the approved conditions of use for certain medically important antimicrobial drugs approved for use in or on the feed of food-producing animals to establish a defined duration of use for those indications that currently lack a defined duration of use. FDA-CVM also published a Federal Register notice that invites the public to comment on specific questions regarding the concept paper until April 12, 2021. (January 8, 2021)
Reminder: FDA funding opportunity: FY 2021 - Extramural medical countermeasure (MCM) regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Proposers are encouraged to submit white papers by January 28, 2021 for FY 2021 award consideration. For more information, including examples of previously funded projects, see MCMi Extramural Research.
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 65 COVID-19-related guidances to date. | | In case you missed it  COVID-19 vaccines FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines |  FDA Insight podcasts Join FDA leaders as they provide their insight into issues facing the agency, including the COVID-19 pandemic and other emerging topics. Recent episodes include compounded drugs and food safety. | Did someone forward you this email? Subscribe.
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