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FDA issues an updated warning against using laparoscopic power morcellators to remove the uterus (hysterectomy) or fibroids (myome...[ Price : $8.95]
U.S. Rep. Gus Bilirakis (R-FL) introduces H.R. 5750, the Orphan Product Extensions Now Accelerating Cures & Treatment Act, which w...[ Price : $8.95]
FDA posts a new guidance on Design Considerations for Devices Intended for Home Use that is intended to assist manufacturers in de...[ Price : $8.95]
Federal Register Notice: FDA requests comments on a new posting on the agencys Web site: Subgroup Data for FDA Approved Products, ...[ Price : $8.95]
Federal Register Notice: FDA releases a final guidance: Registration of Human Drug Compounding Outsourcing Facilities Under Sectio...[ Price : $8.95]
FDA denies an Allergan petition asking FDA to not accept or approve any ANDAs for its Restasis (cyclosporine ophthalmic emulsion) ...[ Price : $8.95]
FDA grants Catabasis Pharmaceuticals an orphan drug designation for CAT-1004 for treating Duchenne muscular dystrophy.[ Price : $8.95]
FDA issues three additional guidance documents to assist firms that compound sterile human drugs with registering as outsourcing f...