2018

In 1992, the USFDA instituted the Accelerated Approval regulations. These regulations allow drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint instead of a large randomized clinical trial. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit of a therapy. Using a surrogate endpoint may enable the FDA to approve these drugs faster and allows the sponsor to reach the market more quickly and at a lower cost compared to traditional phase 3 clinical trials.

You can learn more about the FDA’s fast-track and accelerated approval programs here.

505(b)(2) allows a drug development sponsor to rely upon third-party data without having a right to reference from the original researchers. Examples of such third-party data include published literature or the FDA’s previous finding of safety and effectiveness (i.e., a previous NDA approval).