Subpart D—Orphan-drug Exclusive Approval

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 316
8. ›
9. Subpart D

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 316.31
  § 316.31 Scope of orphan-drug exclusive approval.
• 316.34
  § 316.34 FDA recognition of exclusive approval.
• 316.36
  § 316.36 Insufficient quantities of orphan drugs.