FDA clears a Heidelberg Engineering 510(k) for its Spectralis Flex Module for imaging the posterior segment of pediatric and adult patients in a supin...
Federal Register notice: FDA announces that it approved on 9/17 a product application that redeemed a priority review voucher Novartis Kisqali (riboci...
FDA accepts review a PTC Therapeutics NDA for sepiapterin, indicated for treating pediatric and adult patients with phenylketonuria.
Federal Register notice: FDA corrects a 2/2 final rule on device GMP requirements under the Quality System regulation that omitted the definition of b...
Federal Register notice: FDA announces the Web site location where it is posting two lists of guidance documents that CDRH intends to publish in fisca...
Federal Register notice: FDA announces the revocation of an emergency use authorization issued to Janssen Biotech for the Janssen Covid-19 vaccine.
FDA invites proposals from drug companies to participate in its fiscal year 2025 site visitation program, which is part of the agencys ongoing effort ...
FDA posts an immediately-in-effect guidance titled Temporary Policies for Compounding Certain Parenteral Drug Products that addresses compounding drug...
