Sponsors of drugs approved through the US Food and Drug Administration’s accelerated pathway could be encouraged to produce high quality confirmatory evidence in a more timely way if the approvals are subject to expiration when the evidence is not presented by a specified deadline, the Institute of Clinical and Economic Review suggests in a new white paper.
One way to “fortify requirements for confirmatory evidence is to avoid putting the FDA in the position of having to decide how to proceed when study sponsors fail to produce...