§316.40. Treatment use of a designated orphan drug.
21 C.F.R. § 316.40
Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.
Notes, amendments, and revision history
Amendments
[74 FR 40945, Aug. 13, 2009]
Authority
Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
Source
Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.
Amendments
[74 FR 40945, Aug. 13, 2009]