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Endosseous Dental Implants Performance Criteria Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Ab...

FDA Approves Intraocular Lens for Cataract Surgery

[ Price : $8.95]

FDA approves a Bausch + Lomb PMA for its EnVista Envy intraocular lens for use in cataract surgery.

GSK Plans BLA for Nasal Polyp Therapy

[ 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...

FDA Clears Spectralis Imaging Module

[ Price : $8.95]

FDA clears a Heidelberg Engineering 510(k) for its Spectralis Flex Module for imaging the posterior segment of pediatric and adult...

Priority Voucher Used on Kisqali sNDA

[ Price : $8.95]

Federal Register notice: FDA announces that it approved on 9/17 a product application that redeemed a priority review voucher Nova...

PTC Therapeutics NDA for Treating Phenylketonuria

[ Price : $8.95]

FDA accepts review a PTC Therapeutics NDA for sepiapterin, indicated for treating pediatric and adult patients with phenylketonuri...

Rule on Device GMP Requirements Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 2/2 final rule on device GMP requirements under the Quality System regulation that omitted...

CDRH Web Page on Upcoming Guidances

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Federal Register notice: FDA announces the Web site location where it is posting two lists of guidance documents that CDRH intends...

Janssen Covid Vaccine EUA Revoked

[ Price : $8.95]

Federal Register notice: FDA announces the revocation of an emergency use authorization issued to Janssen Biotech for the Janssen ...

FDA Seeks Drug Firms for Site Visitation Program

[ Price : $8.95]

FDA invites proposals from drug companies to participate in its fiscal year 2025 site visitation program, which is part of the age...