The DC federal court tosses a Jazz Pharmaceuticals suit against FDA over the agencys approval of Avadels narcolepsy drug Lumryz before the end of the ...
Federal Register notice: FDA makes available a final guidance entitled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms and a supplem...
FDA reminds drug compounders to only use ingredients that are suitable for compounding drugs intended to be sterile.
FDA announces extended use dates for some Baxter parenteral products to ease supply issues caused when a Baxter North Carolina facility was hit by Hur...
FDA warns that Chemigroup France is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids.
FDA clears an Exactech 510(k) for the Truliant Porous Tibial Tray, a 3D-printed tibial knee implant.
FDA clears an Imbed Biosciences 510(k) for its Microlyte Ag/Lidocaine, an antimicrobial wound dressing that integrates lidocaine for managing painful ...
AstraZeneca provides four comments to the FDA docket on considerations for generative artificial intelligence/machine learning over a medical devices ...
