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Federal Register notice: FDA announces a 5/15 Allergenic Products Advisory Committee meeting to review DBV Technologies Peanut (Ar...[ Price : $8.95]
Two senior CDER officials discuss how real world data and real world evidence can be used in making regulatory decisions, and desc...[ Price : $8.95]
Taro Pharmaceuticals recalls two lots of phenytoin oral suspension USP, 125 mg/5 mL in 237 mL bottles because it may not re-suspen...[ Price : $8.95]
FDA grants de novo marketing authorization to Asuragens AmplideX Fragile X Dx and Carrier Screen Kit for detecting Fragile X Syndr...[ Price : $8.95]
FDA accepts for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women w...[ Price : $8.95]
FDA clears an Avanos Medical 510(k) for its new, 80-Watt Coolief Radiofrequency system for pain-reducing neurological lesion proce...[ Price : $8.95]
FDA approves a Teva Respiratory supplemental NDA for ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled cor...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Reports of Corrections and...