Draft Guidance for Food and Drug Administration Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy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 draft document entitled "Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)" dated November 2004. The draft guidance document, when finalized, is intended to provide guidance to FDA review staff and sponsors of human gene therapy products on IND submissions, and on the information FDA CMC reviewers record and assess as part of the review of an original IND.