The northern Texas federal court sentences two former dietary supplement company executives to prison and orders two companies to pay a combined $10.7...
Pfizer CEO Albert Bourla says the company and its development partner BioNTech could file an emergency use authorization for their Covid-19 vaccine du...
FDA associate commissioner for regulatory affairs Judith McMeekin says the agency is evaluating whether it can use live or recorded video to conduct m...
Federal Register notice: FDA announces a Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for foreign facilities manufa...
CDRH posts a list of prioritized guidance documents that it intends to publish during fiscal year 2021.
Federal Register notice: FDA announces its Quality Management Maturity for Finished Dosage Forms Pilot Program for domestic drug product manufacturers...
CDRH posts a series of videos highlighting the progress the Center has made to date with implementing the current medical device user fee program.
Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Non-Clinical Assessment of Medical Devices contain...