FDA warns South Koreas Hanlim Pharma about CGMP violations in its manufacturing of finished pharmaceuticals.
CDERs Office of Prescription Drug Promotion says a Facebook post about MannKinds Afrezza misbrands the drug by failing to adequately discuss its serio...
FDA approves EyePoint Pharmaceuticals Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the po...
As part of its continuing push to modernize clinical trials, FDA posts two guidance documents to provide greater clarity and recommendation for drug d...
Presumably to avert new FDA regulations about adding price information in direct-to-consumer ads, Pharmaceutical Research and Manufacturers of America...
Federal Register notice: FDA makes available a draft guidance entitled Rare Diseases: Early Drug Development and the Role of Pre-Investigational New D...
FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdominal aortic aneurysm] S...
FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System.