1. Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs) Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020 Subject(s): Chemistry, PharmaceuticalGenetic TherapyInvestigational New Drug ApplicationDrugs, InvestigationalQuality ControlUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
