FDA Slows Down Accelerated Approval Pathway Products Program

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With drugs taking longer to hit the market, will biopharma’s approval count be affected?

According to data taken by Evaluate Vantage, only 12 percent of novel drugs arrived on the market last year via the FDA’s accelerated approval pathway program. As a result of a new restriction, a further decline of approved medicines can be expected by the end of 2023.


Heavy use of this feature in recent years provided a massive boost to the FDA’s approval count, peaking at 58 percent in 2021. Speedy approval in niche and underserved settings can of course benefit patients in the longer term, but the need to establish both the risks and benefits of these agents, as expeditiously as possible, remains.


The Waxing and Waning of the Speedy Approval. May 15, 2023 / Evaluate