News

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FDA In Brief: FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions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 In Brief: FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

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

FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

Today, the U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants…

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…

Coronavirus (COVID-19) Update: October 26, 2021

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 authorized the…

FDA In Brief: FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products

The following quote is attributed to Linda Katz, director of the FDA's Office of Cosmetics and Colors: Español “The FDA remains dedicated to keeping consumers…