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 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
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
Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
July 4, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has taken important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 Coronavirus by providing guidance with recommendations for those developing COVID-19 Coronavirus vaccines for the ultimate purpose of licensure.
Coronavirus.
FDA Coronavirus (COVID-19) Update: July 1st, 2020
July 1, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
Today, FDA took action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 Coronavirus by providing guidance with recommendations related to licensure for those developing COVID-19 Coronavirus vaccines.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 28th, 2020
June 30, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
The FDA and the Federal Trade Commission (FTC) jointly issued a warning letter to Hong Kong-based SuperHealthGuard and Loyal Great International, Ltd., advising these companies to cease selling unapproved products online to customers in the United States with misleading claims that such products mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.
Coronavirus.
FDA Coronavirus (COVID-19) Update: June 27th, 2020
June 27, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
As part of FDA’s effort to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19 Coronavirus products.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 26th, 2020
June 26, 2020
Silver Spring, MD – The U.S. Food and Drug Administration continues to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
A new FDA Voices, titled Partnering with the European Union and Global Regulators on COVID-19, explains how the FDA and the European Union, including the latter’s European Medicines Agency, have long leveraged each other’s expertise and experience to promote the safety, effectiveness, and quality of medical products to advance the health of our respective citizens.
Coronavirus
Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling
June 21, 2020
Silver Spring, MD – Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19 Coronavirus.
Coronavirus
