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Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, ...[ Price : $8.95]
FDA issues a draft update to guidance for industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Th...[ Price : $8.95]
FDA clears a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for ...[ Price : $8.95]
Dr. Reddys subsidiary Aurigene Oncology halts the development of its psoriasis investigational drug after reporting poor results o...[ Price : $8.95]
FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.[ Price : $8.95]
FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspecti...[ Price : $8.95]
Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem ce...[ Price : $8.95]
FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.