CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 316—ORPHAN DRUGS > SUBPART E—Open Protocols for Investigations (§316.40 to §316.40) > 316.40—Treatment use of a designated orphan drug.

316.40—Treatment use of a designated orphan drug.

Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.

Code of Federal Regulations

[74 FR 40945, Aug. 13, 2009]