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Study finds significant discordance in orphan drug approvals between U.S. FDA and European Medicines Agency (2011-2023)

Jin Ding,

5h ago· 32 min readenInsight

science health public health policy pharmaceutical regulation

Summary

This retrospective observational analysis examines discordance in orphan drug approvals between the U.S. FDA and the European Medicines Agency (EMA) from 2011 to 2023. The study collected data from the FDA Orphan Drug Designations and Approvals Database and the EMA medicines database, using descriptive statistical analysis to identify trends and discrepancies in regulatory outcomes between the two agencies for drugs targeting rare diseases.

Source

bskyStudy finds significant discordance in orphan drug approvals between U.S. FDA and European Medicines Agency (2011-2023)plos.io

Key quotes

· 2 pulled

We collected data on FDA orphan drug approvals between 2011 and 2023 from the FDA Orphan Drug Designations and Approvals Database and their corresponding EMA regulatory status from EMA medicines database.

We used descriptive statistical analysis to examine trends and identify discordance in outcomes between agencies.

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In a retrospective analysis, Jin Ding and colleagues explore the discrepancy in regulatory authorization of orphan drugs by U.S. and European regulatory agencies.

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