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CDER issues a MAPP outlining good review practices for the Office of Clinical Pharmacology review of NMEs, NDAs, and BLAs.[ Price : $8.95]
FDA clears a GI View Ltd. 510(k) for its new Aer-O-Scope Colonoscope System, a disposable, self-propelled, joystick-controlled, co...[ Price : $8.95]
Federal Register Final Order: FDA classifies the Magnetic Surgical Instrument System into Class 2 (special controls).[ Price : $8.95]
Federal Register Notice: FDA announces a 10/25-26 public advisory committee meeting of the Technical Electronic Product Radiation ...[ Price : $8.95]
Federal Register Final Order: FDA classifies the strabismus detection device into Class 2 (special controls).[ Price : $8.95]
CDER director Janet Woodcock says the agency is interested in providing technical expertise on legislation that could curb brand n...[ Price : $8.95]
FDA grants Sanaria a fast track designation for its preventative vaccine for malaria, Sanaria PfSPZ Vaccine.[ Price : $8.95]
FDA warns Hebei Yuxing Bio-Engineering about CGMP deviations in its manufacturing of active pharmaceutical ingredients, and places...