Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs-Reference-Cited by-同舟云学术

Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs

Published:2017 Issue: Volume: Page:183-196
ISSN:0065-2598
Container-title:Advances in Experimental Medicine and Biology
language:
Short-container-title:

Author:

Le Tran T.

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-67144-4_10

Reference16 articles.

1. IOM (Institute of Medicine) (2010) Rare diseases and orphan products: accelerating research and development. The National Academies Press, Washington, DC

2. United States (1983) Orphan drug act, Public Law No. 97-414. Available at: https://history.nih.gov/research/downloads/pl97-414.pdf

3. Braun MM, Farag-El-Massah S, Xu K et al (2010) Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years. Nat Rev Drug Discov 9(7):519–522

4. Hall AK, Carlson MR (2014) The current status of orphan drug development in Europe and the US. Intractable Rare Dis Res 3(1):1–7

5. Heemstra HE, Leufkens HG, Rodgers RP et al (2011) Characteristics of orphan drug applications that fail to achieve marketing approval in the USA. Drug Discov Today 16(1-2):73–80

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