[EA4] Orphan Designations and Approvals in the EU, United States and Japan

[EA4] Orphan Designations and Approvals in the EU, United States and Japan

2015 Value in Health

Korchagina, D. | Tomita, N. | Falissard, B. | Toumi, M. | Tavella, F. | Volume: 18, Issue: 7, Pages: A341,

Since the introduction of orphan legislation the number of orphan drugs has dramatically increased. The objective of the study is to compare orphan designations and approvals in the EU, USA and Japan.

https://www.doi.org/10.1016/j.jval.2015.09.147