FDA Issues Draft Guidance on GCT Product Manufacturing and Comparability

July 17, 2023

The Food and Drug Administration issued a new draft guidance July 13 related to the management of manufacturing changes for human cellular therapy or gene therapy (CGT) products.

The draft guidance, “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry,” provides the agency’s current thinking on the management and reporting of manufacturing changes for CGT products based on a lifecycle approach. It also addresses comparability studies to assess the effect of manufacturing changes on product quality.

FDA is accepting comments on the draft guidance through Sept. 12. All written comments should include the docket number (FDA-2023-D-2436).