A Systematic Evaluation of the Clinical Evidence on Drugs Receiving FDA Accelerated Approval

June 7, 2017

Therapeutic agents that treat serious conditions are eligible for the Food and Drug Administration (FDA) accelerated approval. A new study in the June issue of The Milbank Quarterly has found that these drugs often quickly become part of standard treatment, despite shortcomings in their evidence base. The study, the first to provide a systematic evaluation of all clinical studies conducted on drugs receiving this type of approval, assessed 37 novel therapeutic agents that received accelerated approval between 2000 and 2013.

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