[ Price : $8.95]
FDA issues a guidance on an interim regulatory policy for outsourcing facilities compounding drugs from bulk drug substances.[ Price : $8.95]
FDA puts a partial hold on intrathecal clinical trials of Novartis/AveXis AVXS-101.[ Price : $8.95]
Innovative Health Solutions asks FDA to require preclinical studies and at least one clinical trial to demonstrate substantial equ...[ Price : $8.95]
FDA approves a Biogen NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis.[ Price : $8.95]
FDA grants Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter), a wrist-worn arousal device des...[ Price : $8.95]
FDA approves an Impulse Dynamics PMA supplement for its next generation of the implantable Optimizer Smart System for delivering c...[ Price : $8.95]
CDRHer Charles Viviano explains on a Webinar a new guidance on how the Center is flexible in weighing uncertainty in making medica...[ Price : $8.95]
FDA says an Ethicon recall of its Echelon Flex staplers is Class 1.