21 C.F.R. § 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
Title 21 - Food and 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: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart C—Designation of an Orphan Drug
§ 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
