Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies; Request for Information

The Parenteral Drug Association (PDA) is submitting the attached responses compiled by members of the PDA Advanced Therapy Medicinal Product Advisory Board (ATMP AB) regarding FDA's request for information on Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies. The paper outlined relevant concerns around this issue and the ATMP AB has provided replies to the questions posed by the agency. In the attached comments, the team offers insight and suggestions that may assist the agency in formalizing and finalizing guidance related to cell and gene therapies.