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Regulations last checked for updates: May 16, 2025
Title 21 - Food and Drugs last revised: May 12, 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.
authority:
21 U.S.C. 360aa
,
360bb
,
360cc
,
360dd
,
371
source:
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
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