In a split vote, FDAs Bone, Reproductive and Urologic Drugs Advisory Committee votes 9 to 7 to recommend that the agency remove from the market Amag P...
FDA issues a guidance on an interim regulatory policy for outsourcing facilities compounding drugs from bulk drug substances.
FDA puts a partial hold on intrathecal clinical trials of Novartis/AveXis AVXS-101.
Innovative Health Solutions asks FDA to require preclinical studies and at least one clinical trial to demonstrate substantial equivalence with the IB...
FDA approves a Biogen NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis.
FDA grants Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter), a wrist-worn arousal device designed to prevent res...
FDA approves an Impulse Dynamics PMA supplement for its next generation of the implantable Optimizer Smart System for delivering cardiac contractility...
CDRHer Charles Viviano explains on a Webinar a new guidance on how the Center is flexible in weighing uncertainty in making medical device benefit-ris...