Federal (United States) · Regulations
Part 316 — ORPHAN DRUGS
24 sections
6 groups
- Subpart A — General Provisions4 sections
- Subpart B — Written Recommendations for Investigations of Orphan Drugs3 sections
- Subpart C — Designation of an Orphan Drug11 sections
- Subpart D — Orphan-drug Exclusive Approval3 sections
- Subpart E — Open Protocols for Investigations1 section
- Subpart F — Availability of Information2 sections