1. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2017 Subject(s): Automatic Data Processing -- standardsInvestigational New Drug ApplicationDrug Approval -- legislation & jurisprudenceDrug Approval -- organization & administrationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
