FDA Approves Treatment for Mantle Cell Lymphoma in Adults
The Accelerated Approval program
The FDA started the Accelerated Approval program in 1992, after realizing that studying new drugs could often take years of study before a conclusive and tangible survival benefit could be determined. Rather than waiting and leaving needs unmet for such a long period of time, the FDA set up regulations that allowed drugs treating serious illnesses to be approved based on what they call a surrogate endpoint.
