Article
FDA Issues Draft Guidance On Using The "Plausible Mechanism" Framework To Develop Individualized Therapies For Rare Genetic Diseases
On February 23, 2026, the U.S. Food and Drug Administration released its Draft Guidance for Industry, "Considerations for the Use of Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause".
Foley & Lardner