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Regulatory Strategy, Project Management, and IND Readiness in the Early Development of Selective FGFR2 Inhibitors for FGFR2-Altered Cholangiocarcinoma: A Case Analysis for Pre-IND Meetings and the IND Application for FDA
This article examines early drug development through the lens of regulatory affairs and project management, with emphasis on readiness for Pre-IND meetings and the IND application for FDA. Cholangiocarcinoma is a rare and aggressive cancer of the bile ducts in which a subset of
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