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FDA issues an updated guidance on 510(k) submissions for magnetic resonance diagnostic devices.[ Price : $8.95]
FDA appeals a DC district court decision that it acted arbitrarily and capriciously in denying Ferring five-year exclusivity for i...[ Price : $8.95]
Neos Therapeutics files an NDA for its Amphetamine XR oral suspension drug candidate, NT-0201, an attention-deficit hyperactivity ...[ Price : $8.95]
Former FDA Office of Generic Drugs deputy director turned consultant Gordon Johnston, who pled guilty in June for being part of an...[ Price : $8.95]
The HHS inspector general describes three drug and medical device management and performance challenges facing FDA and the progres...[ Price : $8.95]
The Government Accountability Office says that some states and stakeholders say there have been challenges in FDAs implementation ...[ Price : $8.95]
The International Council on Harmonization says an amendment to its good clinical practice guideline encourages sponsors to implem...[ Price : $8.95]
The federal government arrests former Valeant Pharmaceuticals executive Gary Tanner and former Philidor Rx Services CEO Andrew Dav...