What Do You Think of Faster FDA Approvals?

January 22, 2020

Over the last 4 decades, the US Food and Drug Administration (FDA) has loosened its requirements for approving new drugs, increasingly accepting less data and more surrogate endpoints in clinical trials, and shortening its reviews, according to a new analysis.

Among the evidence is that from 1995 to 1997, 80.6% of new drugs were approved on the basis of two pivotal trials — but that number dropped to 52.8% from 2015 to 2017. A number of programs were enacted during the study period that led to faster approvals, such as fast track and the breakthrough therapy designation.

"The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times," the authors write.


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