What is "accelerated approval" by the FDA?

"Accelerated approval" is a regulatory pathway established by the FDA that allows for faster approval of drugs intended to treat serious conditions and fill an unmet medical need based on surrogate endpoints. Surrogate endpoints are laboratory measurements or physical signs that may predict clinical benefit but are not themselves a direct measure of clinical benefit. This pathway is particularly significant for therapies targeting diseases where conventional clinical endpoints would take a longer duration to measure, thus enabling patients to gain access to potentially beneficial therapies more quickly while still requiring post-marketing studies to confirm the clinical benefits.

This regulatory approach is crucial in the context of urgent public health situations, such as the treatment of cancers or infectious diseases, where timely access to effective treatments can significantly improve patient outcomes. By focusing on surrogate endpoints, the FDA aims to balance the need for swift access to drugs with the necessity for rigorous scientific evaluation of efficacy and safety.