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The International Medical Device Regulators Forum publishes a draft medical device cybersecurity guidance.[ Price : $8.95]
The National Institutes of Health awards $29 million to fund five additional Research Evaluation and Commercialization Hubs to spe...[ Price : $8.95]
FDA accepts for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indica...[ Price : $8.95]
FDA approves a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive...[ Price : $8.95]
Former FDA commissioner Robert Califf accepts a full-time role at Alphabet Company as the head of medical strategy and policy for ...[ Price : $8.95]
FDA clears a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for d...[ Price : $8.95]
FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listi...[ Price : $8.95]
Four pharmaceutical stakeholders suggest edits to the FDA BEST glossary of biomarker, endpoints, and other tools.