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FDA commissioner Margaret Hamburg defends the agencys handling of Zohydro, as USA Today urges that the approval be reconsidered.[ Price : $8.95]
Researchers say FDA needs to do a better job making sure scientific evidence to support 510(k) clearances is publicly available, w...[ Price : $8.95]
CDER Office of Prescription Drug Promotion special assistant to the director Jean-Ah Kang says firms can use reminder-like promoti...[ Price : $8.95]
FDA awards 15 grants totaling more than $19 million to stimulate drug, medical device, and biological product development for pati...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites ArjoHuntleigh, CalComp Nutrition, dōTERRA International, Express Diagnostic...[ Price : $8.95]
FDA releases a discussion paper in preparation for its Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Ampu...[ Price : $8.95]
FDA posts a draft guidance on its Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) that describes a risk-ba...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection information on data to support drug product communications to the Offic...