RE:FDA's Head of CBER wants faster approvals with SE/biomarkersReposted:
July 28, 2023 - The FDA doesn’t “have to get to 100% certainty between an accelerated approval endpoint and a clinical endpoint," according to Peter Marks, MD, PhD and head of the FDA's Center for Biological Evauation and Researh.
One of the ways that new treatment options can happen for rare diseases and orphan drugs is through accelerated approvals, a regulatory pathway whereby drug developers get earlier approval based on data that's likely to predict clinical benefit for serious conditions. Those data points, called surrogate endpoints or biomarkers, differ depending on the disease, but are easier to accrue than clinical endpoints.