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The impact of the Orphan Drug Act on the development and advancement of neurological products for rare diseases: a descriptive review.

Authors
  • Burke, K A
  • Freeman, S N
  • Imoisili, M A
  • Coté, T R
Type
Published Article
Journal
Clinical Pharmacology & Therapeutics
Publisher
Wiley (Blackwell Publishing)
Publication Date
Oct 01, 2010
Volume
88
Issue
4
Pages
449–453
Identifiers
DOI: 10.1038/clpt.2010.193
PMID: 20856241
Source
Medline
License
Unknown

Abstract

Many neurological diseases or conditions are rare disorders. The Orphan Drug Act (ODA) of 1983 was promulgated to promote the development of products for such conditions. In this Opinion piece, we discuss how the ODA has affected neurological diseases, note how current and future sponsors (any person(s) or entity (i.e., academic, corporate body, individual, manufacturer) that applies for an official regulatory action) of products for rare neurological diseases can take advantage of ODA incentives, identify areas of success and continuing needs, and review data that can help drive the future development of products for rare neurological conditions.

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