FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product development

FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product development

Abstract Background The Office of Orphan Products Development (OOPD) of the United States (U.S.) Food and Drug Administration (FDA) has awarded over 700 grants to conduct clinical trials of medicals products for rare diseases since 1983, leading to over 70 marketing approvals. However, despite recen...

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Bibliographic Details
Main Authors: Kathleen L. Miller, Christine Mueller, Gumei Liu, Katherine I. Miller Needleman, Janet Maynard
Format: Article
Language:English
Published: BMC 2020-09-01
Series:Orphanet Journal of Rare Diseases
Subjects:
Clinical trials
Grants
Orphan drug act
Orphan product grants program
Rare diseases
Rare disease medical product development
Online Access:http://link.springer.com/article/10.1186/s13023-020-01514-5

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http://link.springer.com/article/10.1186/s13023-020-01514-5

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