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KemPharm files a formal dispute resolution request over a June FDA complete response letter on an NDA for Apadaz (benzhydrocodone ...[ Price : $8.95]
HealthNewsReview says that FDA product news releases often dont give sufficient detail and context to allow readers to make inform...[ Price : $8.95]
Attorney Peter Hawkes says the 9th Circuit Court of Appeals overturned a lower court decision and found that Arena Pharmaceuticals...[ Price : $8.95]
FDA clears a Neural Analytics 510(k) for the Lucid M1 Transcranial Doppler Ultrasound System, a portable device designed for rapid...[ Price : $8.95]
FDA clears an Arterys 510(k) for its Arterys Software and its use in clinical settings for the quantification of cardiac flow (4D ...[ Price : $8.95]
Federal Register Notice. FDA announces the issuance of two emergency use authorizations for in vitro diagnostic devices for detect...[ Price : $8.95]
Federal Register Notice: FDA asks for comments on an OMB submission seeking an information collection extension on the guidance Pl...[ Price : $8.95]
Federal Register Notice: FDA asks for comments on a request for OMB to extend an information collection on The Protection of Human...