Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy Investigational New Drug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 Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)" dated August 2003. The draft guidance document, when finalized, will provide instructions to CMC reviewers of human somatic cell therapies on what information should be recorded and assessed as part of their review of an original IND. The draft guidance document, when finalized, will also provide CMC reviewers the format in the corresponding human somatic cellular therapy CMC template to prepare their reviews.