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Federal Register notice: FDA seeks comments on an upcoming workshop on advancing model-informed drug development.[ Price : $8.95]
FDA accepts for priority review a Pfizer BLA for TicoVac, its tick-borne encephalitis vaccine for use in individuals one year of a...[ Price : $8.95]
FDA denies Sun Pharmas appeal of a complete response letter for its Taclantis NDA and asks for a new Phase 3 study.[ Price : $8.95]
FDA voices its specific concerns with compounded drugs being used to treat patients with Covid-19.[ Price : $8.95]
Attorney Carolina Wirth says a recent FDA Webinar on monograph reform included timeframes that indicate reform will take several y...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Met...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on a 1/11 notice requesting comments regarding a document entitled Potenti...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for Adverse Experience Reporting for Licensed Biolog...