An FDA inspection of Cadila Healthcares Gujarat, India manufacturing facility leads to a 23-page Form 483 that cites significant GMP violations.
Federal Register notice: FDA submits to OMB an information collection extension for Exports: Notification and Recordkeeping Requirements 21 CFR 1.101...
A Kaiser Health News report examines Medtronics alternative summary reporting exemption that allowed thousands of adverse events associated with the c...
FDA approves a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjun...
FDA announces it has modified organizational structures in the Office of the Commissioner, headquarters organizations, and product Centers.
The U.S. Supreme Court rules that FDA preemption questions are for a judge to decide, not a jury.
FDA clears a Qiagen 510(k) for the multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and identification of multiple respir...
FDA approves an Akorn ANDA for a generic copy of Meda Pharmaceuticals Astelin (azelastine hydrochloride) nasal spray, indicated for treating symptoms ...