Refining FDA’s Plausible Mechanism Framework, Part 2: Manufacturing Challenges, Product Scope, And Post-Approval Considerations Holly Fernandez Lynch,Reshma Ramachandran,Rachel Sachs,Patricia J. Zettler,andSteven Joffe June 9, 2026

https://www.healthaffairs.org/content/forefront/refining-fda-s-plausible-mechanism-framework-part-2-manufacturing-challenges-product?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--nBnpvihW0HWvHY4Pz3GL1k6InTA89dGGz_EjwwFX2MhOwUCx5F_ybjLAvwktur33zc1HsG-YlxVXcHyelgCkuvSvhjg&_hsmi=423554003&utm_source=hasu This is part two of a two-part article offering proposals to improve the FDA’s draft guidance to implement a new approval framework for individualized genetic therapies based on a “plausible mechanism” of action.