This post was written by Areta Kupchyk.

The Institute of Medicine (IOM) has issued a report recommending that Congress grant FDA greater authority to require post-market surveillance of medical products approved primarily on the basis of surrogate endpoints. In the May 12 report entitled “Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease,” the IOM also recommends that FDA better harmonize its approach to evaluate biomarkers across the drug, device, biologic, and food centers, as well as convene expert panels to evaluate biomarkers and biomarker tests intended to have a regulatory impact.