21 C.F.R. Subpart E—Open Protocols for Investigations
Title 21 - Food and Drugs
Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in §312.34 of this chapter.
Title 21: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart E—Open Protocols for Investigations
§ 316.40 Treatment use of a designated orphan drug.
