USA – Human Somatic Cell Therapy : Content and Review of Chemistry, Manufacturing, and Control (INDs)

This guidance document provides to you, sponsors of a human somatic cell 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 somatic cell 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…