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Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for a...[ Price : $8.95]
FDA clears a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiatio...[ Price : $8.95]
Hyman, Phelps & McNamara attorney Kurst Karst says recent staff cuts at FDA that eradicated the Office of Generic Drugs Division o...[ Price : $8.95]
FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic for...[ Price : $8.95]
The Government Accountability Office says HHS should have some mechanism in place to coordinate the activities of various HHS agen...[ Price : $8.95]
FDA approves updated labeling for Idorsias blood pressure drug Tryvio after approving the elimination of a REMS requirement.[ Price : $8.95]
Members of Congress from Maryland, led by Rep. Jamie Raskin, ask to meet with FDA commissioner Martin Makary to discuss their conc...[ Price : $8.95]
Former FDA commissioner David Kessler tells a House hearing that recent FDA staff cuts will adversely affect the U.S.s public heal...