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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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Drug Info J 1997 Jan;31(1):23-5

The United States Orphan Drug ACT: Challenges and Success

Haffner ME


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
DOI: 10.1177/009286159703100104
Includes FDA Authors from Scientific Area(s): Women's Health
Entry Created: 2012-10-24