FDA Guidance for Industry: M4: The CTD - Efficacy Questions and Answers
Title:
FDA Guidance for Industry: M4: The CTD - Efficacy Questions and Answers
Origin/Publisher:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073293.pdf
Document Type:
Guidance
Content:
This guidance specifically addresses questions related to efficacy.