Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.
21 CFR Part 316 · Orphan Drugs
§ 316.40 Treatment use of a designated orphan drug
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 74 FR 40945 13 Aug 2009