21 CFR 316.23 – Timing of requests for orphan-drug designation; designation of already approved drugs
Current as of: 2024 | Check for updates
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(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.
(b) A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition.