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USFDA Draft Guidance: Plausible Mechanism Framework for Individualized Therapies Targeting Specific Genetic Conditions
In February 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry outlining considerations for using a Plausible Mechanism Framework to develop individualized therapies that target specific genetic conditions with a known biological cause. The draft guidance, developed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), describes how developers may generate substantial evidence o
Sharan Murugan
Mar 13 min read