U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Preclinical Assessment of Investigational Cellular and Gene Therapy Products
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Preclinical Assessment of Investigational Cellular and Gene Therapy Products Guidance for Industry November 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-1038
Issued by:
Guidance Issuing Office
Center 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).

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

Questions?

Back to Top