Issue Date: December 1, 2004
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Multidisciplinary
Status: Final
M4: The CTD — Efficacy Questions and Answers
This is one in a series of guidances that provide recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA). This guidance provides answers to questions that have arisen since the finalization of the harmonized CTD guidance documents in November 2000. This guidance specifically addresses questions related to efficacy. Other question and answer (Q &A) guidances are under development to address gener al questions as well as questions related to quality and safety. The questions and answers provided here reflect the consensus of the ICH parties.
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