Refining FDA’s Plausible Mechanism Framework, Part 1: Understanding The Draft Guidance And Clarifying The Framework’s Scope Holly Fernandez Lynch,Reshma Ramachandran,Rachel Sachs,Patricia J. Zettler,andSteven Joffe June 8, 2026

https://www.healthaffairs.org/content/forefront/refining-fda-s-plausible-mechanism-framework-part-1-understanding-draft-guidance-and?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-96C317-2K7_7Mciuqh6TgBOeCcFxghHQPdR7w5NfX0ARlW1mPyGRiPc9EeVv4sS_87_czB1f9Nsrc-SgepTxDWYiz2yQ&_hsmi=423554003&utm_source=hasu This is part one of a two-part article offering proposals to improve the FDA’s guidance to implement a new approval framework for individualized genetic therapies based on a “plausible mechanism” of action.