Posted by Michael Wonder on 04 Aug 2024
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
1 August 2024 - Over the past decades, US Congress enabled the US FDA to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.
This study reviews the FDA’s five special designations for drug development regarding their safety, efficacy/clinical benefit, clinical trials, innovation, economic incentives, development timelines, and price.
