The ISSCR Provides Comments on FDA’s Draft Guidance for Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
On 13 November 2023, the ISSCR submitted comments on the Food and Drug Administration’s (FDA) draft guidance for Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CGT) Products. ISSCR commends FDA’s desire to share its current perspective on the management and reporting of manufacturing changes for CGT products. ISSCR members, who are leading the way in research and innovation will benefit greatly from additional guidance from FDA.
The primary themes of the comments were suggestions for improving organization, requests for clarification and examples, and recommendations for adding new sections. ISSCR believes that these suggestions will contribute to refining the guidance, ensuring that it is easier to understand and follow.