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AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic dev...[ Price : $8.95]
FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel...[ Price : $8.95]
FDA posts 30 signals of serious risks/new safety information identified by the FAERS in the first quarter of 2024 and is evaluatin...[ Price : $8.95]
FDA approves a Cordis PMA for its Mynx Control Venous Vascular Closure Device for use in certain cardiac ablation procedures.[ Price : $8.95]
FDA cautions healthcare providers and facilities to heed a Medtronic urgent recall of all models and lots of its NIM EMG Contact a...[ Price : $8.95]
UniQure says it will meet soon with FDA to discuss potential expedited clinical development pathways and accelerated approval afte...[ Price : $8.95]
FDA warns South Koreas ReBom Co. about CGMP violations in its manufacturing of OTC drugs.[ Price : $8.95]
Inspire Medical Systems recalls its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can...