FDA Standardized NDA Review Format Includes Gender Analysis
Executive Summary
Gender analysis is a required component of FDA's newly instituted standardized format for NDA reviews, the agency said April 18.
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USP Monographs Will Follow International Format For Drug Impurities
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FDA's Office of Postmarketing Drug Risk Assessment will be transferred out of the Office of Review Management to report directly to CDER Deputy Steven Galson, MD, under a reorganization proposal.