21 CFR Part 316 - ORPHAN DRUGS
- Subpart A - General Provisions (§§ 316.1 - 316.4)
- Subpart B - Written Recommendations for Investigations of Orphan Drugs (§§ 316.10 - 316.14)
- Subpart C - Designation of an Orphan Drug (§§ 316.20 - 316.30)
- Subpart D - Orphan-drug Exclusive Approval (§§ 316.31 - 316.36)
- Subpart E - Open Protocols for Investigations (§ 316.40)
- Subpart F - Availability of Information (§§ 316.50 - 316.52)
Source:
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.