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Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry
OtherFDA-2026-D-1256-0002
Comments
154
Last activity Apr 30, 2026
Deadline
Closed on Apr 28, 2026
Closed Apr 28, 2026
Net supportiSupport minus oppose · campaigns included
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Document
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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Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry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
Analysis
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Analyzed 0 of 154 comments
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Not yet analyzed154
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154
Comments over time
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Posted Feb 25, 2026Deadline Apr 28, 2026
Feb 23Mar 9Mar 23Apr 20Apr 27
Support0Oppose0Other0
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- Apr 28, 2026Comment from UCB, Inc.Analysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from California Institute for Regenerative MedicineAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from DEE-P ConnectionsAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from Pharmaceutical Research and Manufacturers of America (PhRMA)Analysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from Sonia VallabhAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from Wave Life SciencesAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from Rare Disease Company CoalitionAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from Adult Polyglucosan Body Disease (APBD) Research FoundationAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from International Society for PharmacoepidemiologyAnalysis pending📎 AttachmentRead comment →
- Apr 27, 2026Comment from American College of Medical Genetics and GenomicsAnalysis pending📎 AttachmentRead comment →
