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Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Sunrise Lee.[ Price : $8.95]
FDA grants RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatme...[ Price : $8.95]
FDA grants Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation System for treating...[ Price : $8.95]
Tidepool files a 510(k) for an automated insulin dosing app for use on the iPhone for managing Type 1 diabetes.[ Price : $8.95]
MDIC says FDA is joining its new Pathology Innovation Collaborative Community.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Safer Technologies Program for Medical Devices.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Neurodegenerative Diseases.[ Price : $8.95]
Teva raises concerns with an FDA compliance policy on bioavailability and bioequivalence samples to be retained.