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FDA posts a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Products.[ Price : $8.95]
FDA extends by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte the...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Annual Status Report Information and Other Submissions for ...[ Price : $8.95]
Federal Register notice: FDA makes available two draft guidances on clinical and non-clinical study recommendations for medical de...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Fostering Medical Device Improvement: Food and Drug Adminis...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Breakthrough Devices Program.[ Price : $8.95]
CDRH develops a Digital Health Frequently Asked Questions Web page to help developers bring innovative technologies to market.[ Price : $8.95]
FDA clears a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine learning algorithms to capture...