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Federal Register Notice: FDA determines that 4,835 days is the regulatory review period for a Medicines Company NDA for Ionsys (fe...[ Price : $8.95]
Three senators ask the Justice Department to investigate whether Mylan deliberately misclassified its EpiPen as a non-innovator dr...[ Price : $8.95]
A one-year study by Chinese drug regulators finds massive fabrication of clinical trials data for drugs awaiting marketing approva...[ Price : $8.95]
FDA and Athersys reach agreement on a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial ...[ Price : $8.95]
FDA adds two Expedited Access Program Data Development Plan examples to its Web site to give formatting suggestions to sponsors.[ Price : $8.95]
FDA accepts for review an Amgen and UCB BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in p...[ Price : $8.95]
CDER conducts a nationwide search for the permanent position of Office of Translational Sciences deputy director for science as cu...[ Price : $8.95]
FDA approves Medtronics MiniMed 670G hybrid closed looped system, the first agency-approved device or artificial pancreas that is ...