- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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-2008-D-0206.