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FDAs Pharmaceutical Science and Clinical Pharmacology Advisory Committee unanimously votes to recommend that CDER move forward wit...[ Price : $8.95]
FDA posts PDUFA 7 updates to the model-informed drug development paired meeting program.[ Price : $8.95]
GSK stops enrollment early due to positive results two Phase 3 trials evaluating gepotidacin, an investigational drug for uncompli...[ Price : $8.95]
FDA says it is working with the National Institutes of Health and the European Medicines Agency on a global substance registration...[ Price : $8.95]
FDA commissioner Robert Califf says FDA and its state and federal partners have made great progress in oversight of drug compoundi...[ Price : $8.95]
FDA posts updated definitions of face-to-face meeting formats to the PDUFA 7 and BsUFA 3 Web pages.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Cross Labeling Oncology Drugs in Combination Regimens.[ Price : $8.95]
Federal Register notice: FDA requests comments on the topics discussed at its 9/14 public workshop entitled Advancing Premarket Sa...