Archive for October, 2021

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…

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 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…

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…

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

FDA In Brief: FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response Español “The FDA, along with the CDC and our…

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency…