Investigating the landscape of US orphan product approvals

Abstract Background The Orphan Drug Act was enacted in 1983 to encourage the development of drugs for rare diseases. Previous research has attempted to examine the impact of the Act by assessing either the number of orphan designations that have been granted or the number of new orphan drugs approve...

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Bibliographic Details
Main Authors: Kathleen L. Miller, Michael Lanthier
Format: Article
Language:English
Published: BMC 2018-10-01
Series:Orphanet Journal of Rare Diseases
Subjects:
FDA
Online Access:http://link.springer.com/article/10.1186/s13023-018-0930-3