§ 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.

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FDA guidance that cites § 316.23

• Tropical Disease Priority Review Vouchers 6 Oct 2016

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 35133 12 Jun 2013