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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Oct 30, 2025
All Titles
Title 21
Chapter I
Part 316
Subpart D - Subpart D—Orphan-drug Exclusive Approval
§ 316.31 - Scope of orphan-drug exclusive approval.
§ 316.34 - FDA recognition of exclusive approval.
§ 316.36 - Insufficient quantities of orphan drugs.
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