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); Availability

PDA appreciates FDAs efforts to further clarify its thinking with respect to the content of the Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications. PDA is pleased to provide detailed comments and recommendations for consideration. PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality. Our comments were prepared by a committee of experts with experience in the practice of pharmacy as well as members representing our Biopharmaceutical Advisory Board and Board of Directors.