21 CFR 316.23 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Orphan Drugs (§ 316.1 To § 316.52) — Designation Of An Orphan Drug (§ 316.20 To § 316.30) — Timing of requests for orphan-drug designation; designation of already approved drugs.

4 Aug 2016

(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.

21 CFR 316.23

[78 FR 35133, June 12, 2013]