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The FDA’s New Pathway for Individual Gene Therapies Is a Bold Shortcut With Real Risks
Key Takeaways
- The FDA is implementing a plausible mechanism pathway for certain individualized gene therapies.
- The framework could allow access without human clinical trials when large studies are not feasible.
- Supporters see faster access for rare-disease patients, while critics warn of weaker evidence and higher risk.
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DT Editorial Team··via livescience.com