Preclinical Assessment of Investigational Cellular and Gene Therapy Products Guidance for Industry November 2013
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
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).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-1038.