Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry
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- Title
- Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry
- Posted
- Feb 25, 2026
- Comment period
- Feb 25, 2026 – Apr 28, 2026
- Topics
Overview
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Stance breakdown
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| Organization | Data standards and privacy | Genetically targeted therapy definition | Plausible mechanism framework | Post-approval data collection |
|---|
18 organization-typed comments could not be identified.
Explorer
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- Apr 28, 2026Comment from Gayle ButterfieldSupportIndividual
A parent of a woman with spinocerebellar Ataxia type 3 expresses support for the proposed guidance to accelerate scientific research and individualized therapies. The commenter argues that patients with rare genetic diseases need fewer regulatory hurdles and more funding to develop life-altering treatments.
Read comment → - Apr 27, 2026Comment from AnonymousSupportIndividualRead comment →