Issue Date: November 1, 2013
Issued by: Center for Biologics Evaluation and Research
Topic(s): Cellular & Gene Therapy, Gene Therapy
Status: Final
Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry
The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue and Gene Therapies (OCTGT) is issuing this guidance to provide 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 cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation, and certain biologic-device combination products which OCTGT (hereinafter referred to as CGT products).
Download the Guidance Document
