FDA clears a Rapid Medical 510(k) for its Comaneci Temporary Coil Embolization Assist Device.
Federal Register notice: FDA announces a 6/20 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting.
FDA approves Pfizer subsidiary FoldRxs NDAs for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for treating heart disease caused by ...
Federal Register notice: FDA makes available a draft guidance entitled Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for...
FDA makes available a final guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
FDA approves a Boston Scientific PMA for the VICI Venous Stent System for treating iliofemoral venous obstructive disease.
Vivimed Life Sciences recalls 19 lots of losartan potassium tablets USP 25 mg, 50 mg, and 100 mg due to the detection of a known carcinogen N-nitroso...
The New York Times editorial board urges FDA to abolish the 510(k) medical device clearance process and fix other device regulatory loopholes amid gro...