FDA pitches faster path to rare-disease therapies
TL;DR
The FDA, led by Dr. Marty Makary in a White House event with President Trump, proposed a new framework to speed approvals for therapies targeting rare diseases.
- FDA proposes new system for approving customized drugs and therapies for rare diseases AP News
- FDA illuminates new approval pathway for bespoke gene therapies Fierce Biotech
- The FDA creates a quicker path for gene therapies NPR
- FDA proposes new treatment approval pathway for ultrarare diseases The Hill
- FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases HHS.gov
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