- When was Edison Oncology Holding Corp founded?
- What is accelerated FDA approval?
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.
- What is a 505(b)2?
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).