Treatment use of a designated orphan drug.
21 C.F.R. § 316.40
in effectEffective: 2024-07-01Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
