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Federal Register notice: FDA makes available a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Ab...[ Price : $8.95]
FDA approves a Bausch + Lomb PMA for its EnVista Envy intraocular lens for use in cataract surgery.[ Price : $8.95]
GSK says it will submit a BLA based on positive data from two Phase 3 trials evaluating depemokimab in chronic rhinosinusitis with...[ Price : $8.95]
FDA clears a Heidelberg Engineering 510(k) for its Spectralis Flex Module for imaging the posterior segment of pediatric and adult...[ Price : $8.95]
Federal Register notice: FDA announces that it approved on 9/17 a product application that redeemed a priority review voucher Nova...[ Price : $8.95]
FDA accepts review a PTC Therapeutics NDA for sepiapterin, indicated for treating pediatric and adult patients with phenylketonuri...[ Price : $8.95]
Federal Register notice: FDA corrects a 2/2 final rule on device GMP requirements under the Quality System regulation that omitted...[ Price : $8.95]
Federal Register notice: FDA announces the Web site location where it is posting two lists of guidance documents that CDRH intends...