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. S12 nonclinical biodistribution considerations for gene therapy products: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023 Subject(s): Genetic TherapyGovernment RegulationResearch DesignUnited States
