GroundRules
21 CFR 316.23: Timing of requests for orphan-drug designation; designation of already approved drugs.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 316—ORPHAN DRUGS
- Subpart C—Designation of an Orphan Drug
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON