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Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-october-20-2020

Oct 20th, 2020 - For Immediate Release: October 20, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Dr. Peter Marks, the Director of FDA's Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and R...

Coronavirus (COVID-19) Update: Daily Roundup October 19, 2020 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-october-19-2020

Oct 19th, 2020 - For Immediate Release: October 19, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to For Our Vets LLC dba Patriot Supreme for selling unapproved products with fraudulent COVID-19 claims. The co...

FDA Issues Stricter Guidelines for Coronavirus Vaccine Developers
https://www.ashclinicalnews.org/online-exclusives/fda-issues-stricter-guidelines-coronavirus-vaccine-developers/

Oct 19th, 2020 - The FDA recently released stricter guidelines for the development of a coronavirus vaccine, calling on developers to provide comprehensive safety data from clinical trials before the agency grants an emergency authorization. The new recommendations, which were submitted for White House approval on September 21 and do not carry the force of law, mean it is highly unlikely that a vaccine could be...

Coronavirus (COVID-19) Update: Daily Roundup October 15, 2020 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-october-15-2020

Oct 15th, 2020 - For Immediate Release: October 15, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA re-issued the Emergency Use Authorization (EUA) for certain filtering facepiece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute fo...

FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China | FDA
https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators

Oct 15th, 2020 - For Immediate Release: October 15, 2020 Today, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).  Under the June 6, 2020 version of...

Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-october-13-2020

Oct 13th, 2020 - For Immediate Release: October 13, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular...