Story perspectives
FDA Fast-Track Drug Approvals Raise Patient Safety Concerns
1/16/2025
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Story summary
- A recent U.S. Department of Health report raises alarms about the FDA's fast-track drug approval process, highlighting serious gaps in safety and efficacy documentation. High-profile drugs like Biogen's Aduhelm and Sarepta's Exondys 51 are under fire for poor record-keeping, prompting the OIG to caution that rushed approvals could jeopardize patient safety.
