21 CFR § 316.23
Timing of requests for orphan-drug designation; designation of already approved drugs
June 25, 2020
(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.
[78 FR 35133, June 12, 2013]
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