Attorney Adrienne Lenz reviews new FDA guidance on the least burdensome requirement for medical device deficiency letter.
FDA's Cellular, Tissue and Gene Therapies Advisory Committee votes unanimously (16 to 0) to recommend approval for a Spark Therapeutics BLA for Luxtur...
Federal Register notice: FDA corrects a final order entitled Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Devic...
Federal Register notice: FDA announces a 3/21/2018 public meeting on Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards...
FDA medical reviewers say Aeries Rhopressa is effective in lowering eye pressure in some patients.
FDA denies an AstraZeneca petition asking that the agency rule on specific aspects of a 505(b)(2) NDA referencing Falsodex IM injection.
The PriceWaterhouseCoopers Health Research Institute says that drug companies face a growing threat from FDA changes to the collection and disseminati...
FDA issues a draft guidance explaining the user fee structures and types of fees under the PDUFA 6 reauthorization.