Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "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)," dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.