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FDA Guidance for Industry: M4E: The CTD - Efficacy

Short Title:
M4EThis guideline presents the common format for the preparatio

Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; ;

Document Type:
This guidance presents the format for the preparation of a well-structured Efficacy section of the CTD for applications that will be submitted to regulatory authorities.

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