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

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products" dated November 2013. The 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 reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products, which OCTGT reviews. The guidance clarifies current expectations regarding the preclinical information that would support an investigational new drug application (IND) and a biologics license application (BLA) for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2012, and supersedes the recommendations in Section VIII in the guidance entitled "Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy" date