21 CFR 316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs.

§ 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
(a) A sponsor may request orphan-drug designation at any time in the drug development process prior to the submission of a marketing application for the drug product for the orphan indication.
(b) A sponsor may request orphan-drug designation of an already approved drug product for an unapproved use without regard to whether the prior marketing approval was for an orphan-drug indication.

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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