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Open Access 01-10-2010 | Oral presentation

Predictors of orphan drug approval

Author: Harald Heemstra

Published in: Orphanet Journal of Rare Diseases | Special Issue 1/2010

Excerpt

To encourage the development of drugs for rare diseases, an orphan drug legislation has been introduced in the USA (1983) and in the EU (2000). Recent literature provides criticism on the slow development of orphan drugs in the EU. This study aims at identifying predictors for successful marketing authorisation of potential orphan drugs in the EU and the US. …

Title: Predictors of orphan drug approval
Author: Harald Heemstra
Publication date: 01-10-2010
Publisher: BioMed Central
Published in: Orphanet Journal of Rare Diseases / Issue Special Issue 1/2010
Electronic ISSN: 1750-1172
DOI: https://doi.org/10.1186/1750-1172-5-S1-O18

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Predictors of orphan drug approval

Excerpt

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