Federal Register notice: FDA announces the availability of a guidance on Qualification of Medical Device Development Tools (MDDT) that is intended to ...
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...