FDA and human somantic cell thearpy INDs

The Center for Biologics Evaluation and Research (CBER) of FDA drafted a Guideline for its Reviewers concerning data on Chemistry, Manufacturing, and Control (CMC) in IND applications for Human Somatic Cell Therapy.
The CMC review instructions and template described in this guidance reflect minimum current review practice for CMC reviewers in the Division of Cellular and Gene Therapies who are involved in the review of somatic cell therapy INDs. FDA expects to update these CMC review instructions and templates as new information, methods, policies, and technologies become available.