1. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Drug ApprovalDrug Industry -- standardsDrugs, GenericGuideline AdherenceInvestigational New Drug ApplicationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
