1. M4E(R2): the CTD--efficacy Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Drug ApprovalInvestigational New Drug ApplicationDrugs, InvestigationalClinical Trials as TopicCongresses as TopicInternational CooperationHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.