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FDA clears a Quidel 510(k) for its Sofia 2 Lyme Fluorescent Immunoassay and its use with the Sofia 2 Fluorescent Immunoassay Analy...[ Price : $8.95]
FDA issues Sunovion Pharmaceuticals a complete response letter rejecting its NDA for dasotraline, a novel dual-acting dopamine and...[ Price : $8.95]
FDA approves Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 ye...[ Price : $8.95]
Federal Register notice: FDA announces a pilot meeting program to allow sponsors to discuss the use of complex innovative trial de...[ Price : $8.95]
FDA grants Insys Therapeutics a fast track designation for its epinephrine nasal spray as an investigational treatment for anaphyl...[ Price : $8.95]
Chain drug stores urge FDA to withdraw a draft guidance on waivers for single, shared system REMS, and other stakeholders also cri...[ Price : $8.95]
An online CDER post describes work of Center statistical researchers in developing complex innovative clinical trial designs.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is modernizing its approach to medical product regulation to support innovation in...