Fast Track Designation: How Aleon Can Help Sponsors Speed Up Their Drug Development to Serve the Underserved

Abstract

From bench to bedside, drug development takes an average of more than ten years. Traditionally, drug development exposes thousands of patients in clinical trials to establish safety and efficacy before reaching the market. In recent years, advancements in drug development, such as targeted therapies in oncology, have shown exceptional and significant efficacy at the early stage of drug testing. Fortunately, health authorities' have adopted expedited programs to help shorten drug development and review timelines for especially promising drugs and biologics. This provides the opportunity for patients with severe and life-threatening diseases to access effective and safe treatment sooner. This position paper discusses one such FDA program known as fast track...