21 CFR 316.40 - Treatment use of a designated orphan drug.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

§ 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