Comment from Personalized Medicine Coalition

Summary: The Personalized Medicine Coalition (PMC), a multi-stakeholder group, supports the FDA's draft guidance on the Plausible Mechanism Framework for developing individualized therapies for rare genetic conditions. They applaud the effort to create a pathway for personalized medicine but urge the FDA to provide further clarification on safety/efficacy data extrapolation, manufacturing standards, and the scope of permissible personalization.