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Nat Rev Drug Discov. 2002 Oct;1(10):821-5.

Two decades of orphan product development.

Author information

1
Office of Orphan Products Development, US Food and Drug Administration, Room 15A08, 5600 Fishers Lane, Rockville, Maryland 20857, USA. mhaffner@oc.fda.gov

Abstract

Over the past 20 years, incentives of the Orphan Drug Act (ODA), the largest single source of extramural clinical grants at the US Food and Drug Administration, have had a substantial impact on public health. ODA incentives have contributed to the development of many innovative biotechnology products, and as our understanding of the human genome evolves, it is anticipated that pharmacogenomics will result in the identification of more 'orphan diseases'.

PMID:
12360259
DOI:
10.1038/nrd919
[Indexed for MEDLINE]

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