FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.
FDA warns the public not to use 15 tests manufactured by Universal Meditech after the company notified the agency that it has stopped all operations a...
FDA addresses whether parametric release is an appropriate control strategy for sterile drug products that are not terminally sterilized.
FDA grants Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating small cell lung cancer...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represented Populations in Cli...
Federal Register notice: FDA makes available a draft guidance entitled Classification Categories for Certain Supplements Under BsUFA III.
Federal Register notice: FDA determines that Baudax Bios Anjeso (meloxicam) solution, 30 mg/mL, was not withdrawn from sale due to safety or effective...
FDA publishes a draft guidance with information on prior approval supplement classification categories A-F.
