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...
FDA posts a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Abutments Performance Criteria for Safety and Performanc...
FDA approves a Pfizer BLA for Hympavzi (marstacimab-hncq) for preventing or reducing bleeding episodes in hemophilia A or B patients.
Sanofi discontinues a Phase 2 study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament light chain levels in...
