U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) Guidance for FDA Reviewers and Sponsors April 2008

Final
Docket Number:
FDA-2008-D-0206
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document provides to you, sponsors of a human gene therapy investigational new drug application (IND), recommendations on the chemistry, manufacturing, and control (CMC) information to include in an original IND. This guidance also applies to combination products that contain a human gene therapy biological product in combination with a drug or device as part of the final product. Also, this guidance instructs FDA CMC reviewers about the information to record and assess as part of an IND review, taking into consideration the various manufacturing challenges for these products. 


Submit Comments

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-2008-D-0206.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010