CBER issues a standard operating policy and procedure staff guide on administrative processing and review management procedures for INDs received by t...
AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic devices for immediate p...
FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel disease pouchitis.
FDA posts 30 signals of serious risks/new safety information identified by the FAERS in the first quarter of 2024 and is evaluating the need for regul...
FDA approves a Cordis PMA for its Mynx Control Venous Vascular Closure Device for use in certain cardiac ablation procedures.
FDA cautions healthcare providers and facilities to heed a Medtronic urgent recall of all models and lots of its NIM EMG Contact and Standard endotrac...
UniQure says it will meet soon with FDA to discuss potential expedited clinical development pathways and accelerated approval after reporting positive...
FDA warns South Koreas ReBom Co. about CGMP violations in its manufacturing of OTC drugs.
