1. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019 Subject(s): Guidelines as TopicConsensusDevice ApprovalDrug ApprovalGovernment AgenciesVoluntary ProgramsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.Center for Biologics Evaluation and Research (U.S.)
