Archive for January, 2022

Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine

Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine…

FDA Roundup: January 28, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: As part of the FDA’s efforts to…

FDA Roundup: January 21, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced two FY 2022…

FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

Today, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the health of all women, the Center for Devices…

FDA Roundup: January 14, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the Interagency Food Safety Analytics Collaboration…

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

Today, the U.S. Food and Drug Administration released a white paper developed by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) that contains…

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species

Today, the U.S. Food and Drug Administration approved Solensia (frunevetmab injection), the first treatment for the control of pain associated with osteoarthritis in cats and…

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion…

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single…