FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation of the devices therm...
FDA publishes for comment an updated draft guidance on requesting feedback and meetings with FDA on medical device submissions.
Four stakeholders suggest ways for FDA to improve its draft guidance on advanced manufacturing technologies designation.
FDA grants Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell memory-rich chimeric an...
FDA clears an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that is intended to facilitate an optimal fit within t...
Johnson & Johnsons Medos International Sarl device unit recalls its Cerebase DA Guide Sheath after receiving an increase in complaints about fractures...
Federal Register notice: FDA corrects a 12/18 notice that announced the withdrawal of a Chartwell RX Sciences NDA for Flowtuss.
Federal Register notice: FDA makes available a draft guidance entitled E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and...
