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.)
2. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023 Subject(s): Drug IndustryGovernment RegulationReference StandardsRegenerative Medicine -- legislation & jurisprudenceRegenerative Medicine -- standardsVoluntary ProgramsUnited StatesCenter for Biologics Evaluation and Research (U.S.)
