Federal Register Notice: FDA is making available Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products. It provides recommendations for sponsors and individuals who design and implement preclinical studies on the substance and scope of preclinical information needed to support 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. It clarifies current expectations on the preclinical information that would support an IND and a BLA. This guidance finalizes the draft guidance of the same title dated 11/2012, and supersedes the recommendations in Section VIII in the Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy dated 3/1998. To view this notice, click here.