FDA Coronavirus (COVID-19) Update: July 15th, 2020
July 15, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA has posted an updated Coronavirus Treatment Acceleration Program (CTAP) webpage. The webpage provides information about CTAP’s purpose, strategy and operations.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 14th, 2020
July 14, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
FDA scientists have identified specific areas of the so-called spike proteins on the surface of the COVID-19-casuing virus that appear to be key to triggering strong protective antibody responses in rabbits exposed to the virus.
Coronavirus
Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test
July 12, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a COVID-19 Coronavirus antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 11th, 2020
July 11, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA issued a statement in conjunction with preparations to resume domestic inspections, guided by a new a risk-assessment system.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 10th, 2020
July 10, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Coronavirus
FDA Coronavirus (COVID-19) Update: July 9th, 2020
July 9, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
As part of the FDA’s effort to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19-related products.
Coronavirus.
FDA Coronavirus (COVID-19) Update: July 8th, 2020
July 8, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Yesterday, the FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers alerting them of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 7th, 2020
July 7, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”
Coronavirus
Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
July 6, 2020
Silver Spring, MD – As part of continued action to protect the American public, the U.S. Food and Drug Administration (FDA) is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested.
Coronavirus
FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season
July 5, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 Coronavirus pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 Coronavirus by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC).
Coronavirus
