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.
FDA approves a Teva Respiratory supplemental NDA for ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid for asth...
FDA Review posts the Federal Register notices for the week ending 2/21/2020.