Posts Tagged: Infectious Disease

Coronavirus (COVID-19) Update: May 28, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: This week, FDA released…

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate…

Coronavirus (COVID-19) Update: May 25, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, the FDA updated…

Coronavirus (COVID-19) Update: May 21, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued a reminder to…

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Making COVID-19 vaccines widely available…

Coronavirus (COVID-19) Update: May 18, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On May 17, the…

Coronavirus (COVID-19) Update: May 14, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the…

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic

Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019…

Coronavirus (COVID-19) Update: May 7, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the…

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the…