21 CFR § 316.40 Orphan Drugs

§ 316.40 Treatment use of a designated orphan drug.

Current through Sep 8, 2026 · Read all of Part 316

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]

← § 316.36 Insufficient quantities of orphan drugs.§ 316.50 Guidance documents. →