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 Gene Therapy Investigational New Drug Applications (INDs). It provides recommendations to sponsors on the CMC information to include in an original IND for human gene therapy. It also provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The document finalizes a 2004 draft guidance. To download this guidance, click here. To view this notice, click here.