C.F.R. » Title 21 » 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

21 C.F.R. § 316.40

Treatment use of a designated orphan drug

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

[74 FR 40945, Aug. 13, 2009]