Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors

Issue Date: April 1, 2008
Issued by: Center for Biologics Evaluation and Research
Topic(s): Cellular & Gene Therapy, Gene Therapy
Status: Final

Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors

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.

Download the Guidance Document