1. Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial: guidance for industry Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, November 2022 Subject(s): Cell- and Tissue-Based TherapyClinical Trials as TopicGenetic TherapyGovernment RegulationUnited StatesUnited States. Food and Drug Administration
2. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020 Subject(s): Biological ProductsTissuesCell- and Tissue-Based TherapyTissue TransplantationUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
