Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ 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.
§ 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.