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: - February 23, 2021: COVID-19 Update including guidances for medical product developers to address the emergence and potential future emergence of variants of SARS-CoV-2
- February 22, 2021: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
- February 19, 2021: COVID-19 Update including a warning letter for selling an unapproved product with fraudulent COVID-19 claims.
- February 19, 2021: FDA warns about limitations and accuracy of pulse oximeters - Also see the updated Consumer Update, Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy
- February 18, 2021: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
- February 16, 2021: FDA Voices - Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges
- February 16, 2021: COVID-19 Update including a warning letter for selling unapproved products, including unapproved products with fraudulent COVID-19 claims
- February 12, 2021: COVID-19 Update including an EUA for a monoclonal antibody combination for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19; and a revised guidance, Investigational COVID-19 Convalescent Plasma
Bookmark www.fda.gov/coronavirus for the latest. | |  |  Health Equity and COVID-19: What Minority Communities Need to Know February 25, 2021, 6:00 - 7:00 p.m. ET Join the FDA's Office of Minority Health and Health Equity for a conversation about health equity and COVID-19 with Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, and RADM Richardae Araojo, Associate Commissioner for Minority Health, and Director of the FDA Office of Minority Health and Health Equity. Learn about the latest COVID-19 updates, including information about vaccines and the FDA's approval process. COVID-19 vaccine updates COVID-19 vaccine safety surveillance FDA recently posted a new web page, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA's Center for Biologics Evaluation and Research (CBER) is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention (CDC), the Center for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), and other academic and large non-government healthcare data systems. Watch the VRBPAC meeting live On February 26, 2021, 9:00 a.m. - 5:30 p.m. ET, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. Watch live on YouTube. USDA, FDA underscore current epidemiologic and scientific information indicating no transmission of COVID-19 through food or food packaging Statement from Acting USDA Secretary Kevin Shea and Acting FDA Commissioner Janet Woodcock, M.D. After more than a year since the COVID-19 outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention continue to underscore that there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19. Upcoming events - New! February 25, 2021: Health Equity and Covid-19: What Minority Communities Need To Know webinar, 6:00 p.m. ET. Please register in advance.
- February 26, 2021: Vaccines and Related Biological Products Advisory Committee meeting (webcast) to discuss the EUA request for a COVID-19 vaccine from Janssen Biotech Inc.
- March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data (Zoom webcast), 3:00 - 4:00 p.m. ET - This Center of Excellence in Regulatory Science and Innovation (CERSI) lecture is presented by Atul Butte, MD, PhD, University of California, San Francisco (UCSF) -Stanford CERSI. Registration is not required.
- New! March 12, 2021: 365 Days and Counting: COVID-19's Impact on the Oncology Community Zoom webinar, 11:00 a.m. - 12:00 p.m. ET, hosted by the FDA Oncology Center of Excellence. Please register in advance.
- 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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