FDA: Rare Drugs Could Soon See More Expedited Approvals

According to a recent FierceBiotech article, the FDA's Center for Biologics Evaluation and Research director, Peter Marks, revealed that the agency is considering ways to expand accelerated approvals for drugs targeting rare diseases. Marks stated that the FDA now has a better understanding of the data needed to grant accelerated approvals, allowing more drugs to potentially receive quicker authorization. Accelerated approvals rely on surrogate endpoints or biomarkers, which can predict clinical benefit more easily than traditional clinical endpoints.