News

Coronavirus (COVID-19) Update: August 13, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort…

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

On Fri., Aug. 13, 2021, the Centers of Disease Control and Prevention’s Advisory Committee on Immunization Practices outlined clinical recommendations  regarding an additional dose of…

FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment

The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is an uncommon chronic sleep…

Coronavirus (COVID-19) Update: August 6, 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, FDA announced that…

FDA Approves New Treatment for Pompe Disease

Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset…

FDA In Brief: FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers

The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition “The FDA is committed to ensuring…

FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices

Today, the U.S. Food and Drug Administration announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are…

Coronavirus (COVID-19) Update: August 3, 2021

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

Coronavirus (COVID-19) Update: July 30, 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 revised…

FDA In Brief: FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

The following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products “Today, the FDA issued a warning letter to a…