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: Upcoming events - 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.
Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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