FDA clears an Ultromics 510(k) for its image analysis system EchoGo Core, which uses artificial intelligence to automate the analysis and quantificati...
Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices: Current Good Manufacturing Practice Quality Syste...
FDA warns Dollar Tree about its receipt of over-the-counter drugs manufactured by foreign contract firms that have received FDA Warning Letters for ma...
FDA accepts for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofibromatosis type 1 an...
CGMP consultant Dave Elder analyzes a draft International Conference on Harmonization guidance on technical and regulatory considerations for drug pro...
Former CDRH branch chief Morris Waxler tells CBS News LASIK eye surgery should be pulled from the market due to complications.
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to not recommend approval of Eli Lilly and Boehringer Ingelheims empagliflozin 2.5 mg...
FDA says the Botanical Safety Consortium has been formally convened under a memorandum of understanding between FDA and two research groups