CDRH answers frequently asked questions about its new medical device pre-certification program.
United Therapeutics sues FDA to get orphan drug exclusivity for its Orenitram extended-release tablets for treating pulmonary arterial hypertension.
FDA issues a safety alert update based on receiving five reports of unanticipated deaths since 2016 in patients with liquid-filled intragastric balloo...
FDA issues a safety alert on sterile drug products that are produced and distributed nationwide by Vital Rx Inc. (dba Atlantic Pharmacy and Compoundin...
Federal Register notice: FDA announces a 9/8 Medical Imaging Drugs Advisory Committee meeting.
Pharmaceutical Manufacturing Research Services asks a federal court to compel FDA to respond to its petition seeking a stay of agency approval of Insp...
The General Services Administration says it is preparing an environmental impact statement to analyze the impacts of increasing FDA staff at the White...
Sen. Charles Grassley says the public needs to know when doctors and other providers are receiving payments from drug companies.