FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.
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.