Michaeli, Daniel Tobias; Michaeli, Thomas; Albers, Sebastian - In: The European Journal of Health Economics 25 (2023) 6, pp. 979-997
: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. Objectives: This study reviews the FDA … analyzing the impact of the FDA's special designations (orphan, fast track, accelerated approval, priority review, and …