Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
All TitlesTitle 21Chapter IPart 316Subpart E - Subpart E—Open Protocols for Investigations
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
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