Federal Register notice: FDA makes available a draft guidance entitled Immunogenicity Information in Human Prescription Therapeutic Protein and Select...
Federal Register notice: FDA makes available a final guidance entitled Population Pharmacokinetics.
Federal Register notice: FDA makes available a revised draft guidance entitled Assessment of Pressor Effects of Drugs.
Federal Register notice: FDA classifies Apples photoplethysmograph analysis software for over-the-counter use into medical device Class 2.
FDA accepts for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating ...
In a move to gain Senate backing of his FDA commissioner nomination, Robert Califf promises once in office to crack down on drug companies that gain a...
FDA issues a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test due to concerns about false results.
FDA removes its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 now that Covid-19 cases are dramatically dec...