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FDA issues a draft guidance with recommendations for drug application sponsors about nonclinical studies to identify potential end...[ Price : $8.95]
GPhA asks FDA to assign the same International Non-proprietary Naming names to biosimilars and their reference protein products.[ Price : $8.95]
FDA clears a Crosstrees Medical 510(k) for the Crosstrees PVA Pod System for Percutaneous Vertebral Augmentation.[ Price : $8.95]
CDER Office of Compliance deputy director Ilisa Bernstein says her office is ratcheting up its surveillance of drug sponsors use o...[ Price : $8.95]
Federal Register Notice: FDA plans a public hearing 12/4 to the formulation, manufacturing, and labeling of currently marketed eme...[ Price : $8.95]
FTC commissioner Julie Brill makes the case for working to overturn anti-competitive pay-for-delay settlements.[ Price : $8.95]
Researchers say that 60% of Rx drug TV ads and 80% of OTC drug TV ads contain false or potentially misleading statements.[ Price : $8.95]
Stakeholders call on FDA to make significant changes to a draft cyber security guidance document for medical devices.