Part 316 — Orphan Drugs
- Subpt. A General Provisions §§316.1 to 316.4
- Subpt. B Written Recommendations for Investigations of Orphan Drugs §§316.10 to 316.14
- Subpt. C Designation of an Orphan Drug §§316.20 to 316.30
- Subpt. D Orphan-drug Exclusive Approval §§316.31 to 316.36
- Subpt. E Open Protocols for Investigations §316.40
- Subpt. F Availability of Information §§316.50 to 316.52