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Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Experience Reporting For Licen...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled Applications for FDA Approval to Market...[ Price : $8.95]
FDA approves an Amicus Therapeutics NDA for Pombiliti (cipaglucosidase alfa-atga) in combination with Opfolda (miglustat) 65mg cap...[ Price : $8.95]
According to Reuters, FDA says it is doing a thorough review of 265 reports of suicidal thoughts or behavior that may be associate...[ Price : $8.95]
FDA publishes a guidance on technical considerations for medical devices that use physiologic closed-loop control technology with ...[ Price : $8.95]
FDA publishes a draft guidance to assist sponsors in developing various types of products to prevent or treat graft-versus-host di...[ Price : $8.95]
FDA approves a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major dep...[ Price : $8.95]
FDA approves a new indication for Pfizers Bosulif to treat some pediatric patients with chronic myelogenous leukemia.