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Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

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This cross-sectional study examines how often and in what combinations 4 US Food and Drug Administration programs for expedited development and review of novel drugs were used among orphan and… Click to show full abstract

This cross-sectional study examines how often and in what combinations 4 US Food and Drug Administration programs for expedited development and review of novel drugs were used among orphan and nonorphan biologics and small-molecule drugs approved between 2008 and 2021.

Keywords: novel drugs; food drug; orphan nonorphan; drug administration; drug; development review

Journal Title: JAMA Network Open
Year Published: 2022

Link to full text (if available)


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