Federal Register notice: FDA seeks comments on its draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange for electr...
FDA releases the FDA-483s issued following two separate 2021 inspections at Chinas WuXi Biologics.
Two former JHL Biotech executives are sentenced to prison time and supervised release for conspiring to steal Genentech trade secrets and wire fraud.
FDA says a Celltrion USA recall of a Covid-19 rapid test due to a high rate of false-positive results is Class 1.
FDA seeks comments on an information collection extension for medical device accessories.
Federal Register notice: FDA sends to OMB and information collection revision entitled MedWatch: The FDA Safety Information and Adverse Event Reportin...
Five persons are indicted on federal charges of conspiracy to smuggle prescription drugs and money laundering conspiracy.
Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Chimeric Antigen Receptor T Cell Products...