HPR20 The Landscape of U.S. Orphan Product Designations and Approvals

H Althobaiti,R Rodriguez-Monguio,L Brown, E Seoane-Vazquez

VALUE IN HEALTH（2022）

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摘要

Rare disease drug approvals have accelerated significantly since the passage of the 1983 Orphan Drug Act (ODA). This study aims to analyze the characteristics of orphan drugs designations and approvals in the U.S. market during the period 1983–2020 and to assess the factors explaining the trends in orphan drug approvals.

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