21 C.F.R. § 316.23

Current through October 31, 2024
Section 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 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 C.F.R. §316.23

78 FR 35133 , June 12, 2013