Scientific Publications by FDA Staff
Drug Info J 1997 Jan;31(1):23-5
The United States Orphan Drug ACT: Challenges and Success
The Orphan Drug Act, by providing incentives to pharmaceutical firms to develop new drugs for rare diseases, has helped many patients in the United States. This paper reviews its progress from its passage in 1983 to date, including the designation of 643 orphan products and the marketing approval of 125 of these. The next goal is to achieve harmonization with the European Union and Japan.
|Category: Journal Article|
|Includes FDA Authors from Scientific Area(s): Women's Health|
|Entry Created: 2012-10-24|