FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.
FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for treating invasive aspe...
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Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represented Populations in Cli...
Federal Register notice: FDA makes available a draft guidance entitled Classification Categories for Certain Supplements Under BsUFA III.
