An FDA safety communication advises that testing for monkeypox virus should use swab samples taken directly from a lesion to avoid false test results.
Federal Register proposed rule: FDA proposes to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to use certain methods o...
Federal Register notice: FDA revokes the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell SARSCoV2 Coronavirus ...
Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription Drug and Biological...
FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic ...
The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.
Hospira recalls one lot of propofol injectable emulsion due to the presence of a visible particulate in a single retained vial from the lot.
FDA solicits comments on software functions excluded from the medical device definition by the 21st Century Cures Act.