Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products," dated November 2012. The draft guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products regulated by the Center for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current expectations regarding the preclinical information that supports an investigational new drug application (IND) and a biologics license application (BLA) for these product areas.