FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.
Despite being removed from her post, controversial former FDA chief spokeswoman Emily Miller remains at the agency as senior advisor to chief of staff...
Federal Register notice: FDA seeks nominations for voting members to serve on its Device Good Manufacturing Practice Advisory Committee and the Medica...
CDRH posts a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.
Attorney Sara Koblitz says a Federal Circuit Court of Appeals decision casts doubt on the long-established practice of generic drug companies carving ...
FDA issues a guidance on technical considerations for non-clinical assessment of medical devices containing nitinol.
Six drug companies submit technical comments on an FDA draft guidance on drug development for acute myeloid leukemia.
FDA says it will exercise enforcement discretion for some modifications to molecular influenza tests during the Covid-19 pandemic.