FDA: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information

This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for an LBP. This guidance 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).