Federal Register Notice: FDA is making available a document, Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs). It provides recommendations to sponsors on the CMC information to include in an original IND for human somatic cell therapy and instructions to FDA reviewers on information to record and assess as part of the IND review. It finalizes a 2003 draft guidance. To download this guidance, click here. To view this notice, click here.