1. Regulations
  2. title 21
  3. chapter I-i4
  4. part 316
  5. subpart E
  6. § 316.40

View all text of Subpart E [§ 316.40 - § 316.40]

§ 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.

[74 FR 40945, Aug. 13, 2009]

AUTHORITY: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.

SOURCE: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

CITE AS: 21 CFR 316.40