FDA tweaks orphan drug rules

06/13/2013 | Regulatory Focus

The FDA has finalized changes to rules implementing the Orphan Drug Act. Under the new rules, "orphan subset" means a drug is appropriate for use in a subset of the population but not in the broader population. The agency also clarified that a drug may qualify for incentives even if it could be used to treat multiple patient populations, as long as each one is less than 200,000 patients.

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