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.