Explaining FDA’s Caution on New Surrogates to New Patient Constituencies
This article was originally published in RPM Report
Executive Summary
When is a surrogate marker good enough for approval, accelerated or otherwise? That is not an easy concept to explain, but FDA is doing its best to educate patient advocates on the nuances of the regulatory process. Here is how FDA tried during a recent webinar for Duchenne Muscular Dystrophy patients.