Comment from Institute for Gene Therapies (IGT)
AnonymousSupportAdvocacy
Summary: The Institute for Gene Therapies (IGT), a multi-stakeholder coalition representing patient advocacy groups and gene therapy manufacturers, supports the FDA's Draft Guidance for the Plausible Mechanism Framework. They advocate for greater regulatory flexibility for rare diseases and request additional companion guidance to provide specific definitions, scenario examples, and clearer paths to licensure for individualized therapies.
The Institute for Gene Therapies (IGT) is pleased to submit these comments to the FDA’s Draft Guidance for Industry regarding “Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause."