FDA Issues Draft “Plausible Mechanism” Guidance

On Monday, Feb. 23, the Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause.” FDA Commissioner Marty Makary first presented the concept of a “plausible mechanism” framework in a podcast appearance on April 17, 2025, and was later expanded in a Nov. 12, 2025, New England Journal of Medicine article that announced,... By: Brownstein Hyatt Farber Schreck