FDA To Name Surrogate Endpoints To Be Used For Drug Approvals

FDA soon will publish a list of surrogate endpoints that have already been used as the basis for drug and biologics approvals, FDA Commissioner Scott Gottlieb told stakeholders Monday (June 25). Gottlieb added that FDA will provide guidance to drug developers on how to design trials based on the use of biomarkers as novel surrogate endpoints for traditional and accelerated drug approvals, and the agency will be accepting so-called Type C meeting requests from sponsors. Gottlieb laid out the plan...