FDA

Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests

Today, the U.S. Food and Drug Administration is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further…

FDA Approves Treatment for Rare Blood Disease

Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction…

Coronavirus (COVID-19) Update: November 12, 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 November 9, 2021,…

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive…

Coronavirus (COVID-19) Update: November 5, 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, Friday, November 5,…

FDA In Brief: FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “As…

Coronavirus (COVID-19) Update: November 2, 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 Friday, October 22,…

Coronavirus (COVID-19) Update: October 29, 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 Friday, October 22,…

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5…

FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases

The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene…