Coronavirus Disease 2019 (COVID-19) Update

If your email program has trouble displaying this email, view as a webpage. FDA Office of Minority Health and Health Equity Coronavirus Disease 2019 (COVID-19) updates Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: March 23, 2021: COVID-19 Update including a warning letter to a company selling unapproved products with fraudulent COVID-19 claims March 19, 2021: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection March 19, 2021: COVID-19 Update including a web page with screening information for newly established testing programs March 18, 2021: FDA's Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic March 18, 2021: Examining Our Covid-19 Response: An Update From Federal Officials - Congressional testimony by Peter Marks, M.D., Ph.D., Director, FDA Center for Biologics Evaluation and Research (CBER) March 17, 2021: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process March 17, 2021: Leading the Way Forward: Biden Administration Actions to Increase Covid-19 Vaccinations - Congressional testimony by Peter Marks, M.D., Ph.D., Director, FDA CBER Bookmark www.fda.gov/coronavirus for the latest.   Help stop the spread of coronavirus and protect your family The COVID-19 pandemic requires that we remain vigilant in our daily lives until we can safely return to everyday activities. We can each take some simple steps to help slow the spread of coronavirus disease and protect ourselves, our families, and our communities. The steps are: Get a COVID-19 vaccine. Wash your hands often with plain soap and water. Cover your mouth and nose with a mask when around others. Avoid crowds and practice social distancing (stay at least 6 feet apart from others).   FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process FDA granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) (PDF), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA's response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. (March 17, 2021) Upcoming events 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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