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Attorney Adrienne Lenz reviews new FDA guidance on the least burdensome requirement for medical device deficiency letter.[ Price : $8.95]
FDA's Cellular, Tissue and Gene Therapies Advisory Committee votes unanimously (16 to 0) to recommend approval for a Spark Therape...[ Price : $8.95]
Federal Register notice: FDA corrects a final order entitled Medical Devices; Neurological Devices; Classification of Cranial Moti...[ Price : $8.95]
Federal Register notice: FDA announces a 3/21/2018 public meeting on Prescription Drug User Fee Act of 2017; Electronic Submission...[ Price : $8.95]
FDA medical reviewers say Aeries Rhopressa is effective in lowering eye pressure in some patients.[ Price : $8.95]
FDA denies an AstraZeneca petition asking that the agency rule on specific aspects of a 505(b)(2) NDA referencing Falsodex IM inje...[ Price : $8.95]
The PriceWaterhouseCoopers Health Research Institute says that drug companies face a growing threat from FDA changes to the collec...[ Price : $8.95]
FDA issues a draft guidance explaining the user fee structures and types of fees under the PDUFA 6 reauthorization.