Remdesivir’s Path To Orphan Designation Could Be Exploited By Others, Experts Warn

 
• By Derrick Gingery

Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.

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If the loophole is not closed, more sponsors could follow the pathway that allowed remdesivir to receive an orphan drug designation as a coronavirus treatment, the writers of a JAMA Internal Medicine article argued. • Source: Shutterstock

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