Review of Evidence Supporting 2022 US Food and Drug Administration Drug Approvals
Pub TLDR
This study highlights a shift towards more lenient evidence standards for FDA drug approvals since the enactment of the 21st Century Cures Act in 2017, with a significant number of drugs approved based on limited evidence.
The authors call for greater transparency and access to all evidence for consumers to make informed decisions about their medications.
College of Health researcher(s)
OSU Profile
Abstract
The 21st Century Cures Act, enacted in 2017, gave the US Food and Drug Administration (FDA) greater flexibility to apply evidence-based standards for novel drug approvals. To evaluate current practice, we summarize evidence supporting the 37 drugs approved in 2022.