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FDA posts a cross-Center paper entitled Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Requests for Feedback and Meetings for Medical Device Submi...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Thermal Effects of Medical Devices That Produ...[ Price : $8.95]
Federal Register notice: FDA amends certain medical device regulations to update a citation for information collection and conform...[ Price : $8.95]
FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation ...[ Price : $8.95]
FDA publishes for comment an updated draft guidance on requesting feedback and meetings with FDA on medical device submissions.[ Price : $8.95]
Four stakeholders suggest ways for FDA to improve its draft guidance on advanced manufacturing technologies designation.[ Price : $8.95]
FDA grants Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell mem...