Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Guidance for Industry June 2016
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance is intended to provide sponsors of Investigational New Drug Applications (INDs) with recommendations on submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States (U.S.), including LBPs lawfully marketed as foods (such as conventional foods and dietary supplements) in the U.S. and proposed for clinical uses regulated under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).
This guidance focuses on the chemistry, manufacturing, and control (CMC) information and is applicable to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise under Title 21 of the Code of Federal Regulations Part 312 (21 CFR Part 312). This guidance is not applicable to LBPs intended as gene therapy vectors, to oncolytic bacteria, or to oncolytic viruses.
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-2010-D-0500.