Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for additional informatio...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