New FDA approval process promotes development of rare disease gene therapies | Hogan Lovells...

TL;DR


Summary:
- The article discusses a new FDA approval process called the Accelerated Approval pathway, which allows for faster approval of certain drugs that treat serious or life-threatening conditions.
- This new process is designed to get important new treatments to patients more quickly, by relying on "surrogate endpoints" rather than waiting for the full clinical trial data.
- The article explains that this approach can help speed up the development and approval of innovative drugs, but also highlights the need for careful monitoring and post-approval studies to ensure the drugs are safe and effective.

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