Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceut...
Federal Register notice: FDA seeks comments on a draft Electronic Common Technical Document v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Mod...
Federal Register notice: FDA announces a 5/15 Allergenic Products Advisory Committee meeting to review DBV Technologies Peanut (Arachis hypogaea) Alle...
Two senior CDER officials discuss how real world data and real world evidence can be used in making regulatory decisions, and describe challenges to e...
Taro Pharmaceuticals recalls two lots of phenytoin oral suspension USP, 125 mg/5 mL in 237 mL bottles because it may not re-suspend when shaken.
FDA grants de novo marketing authorization to Asuragens AmplideX Fragile X Dx and Carrier Screen Kit for detecting Fragile X Syndrome.
FDA accepts for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women with advanced ovarian...
FDA clears an Avanos Medical 510(k) for its new, 80-Watt Coolief Radiofrequency system for pain-reducing neurological lesion procedures.