GroundRules
21 CFR 316.40: Treatment use of a designated orphan drug.
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 E—Open Protocols for Investigations
Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.
Collected 2026-08-27T02:24:47Z. Source file · JSON