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Regulations last checked for updates: Jun 14, 2025
Title 21 - Food and Drugs last revised: Jun 03, 2025
All Titles
Title 21
Chapter I
Part 316
Subpart C - Subpart C—Designation of an Orphan Drug
§ 316.20 - Content and format of a request for orphan-drug designation.
§ 316.21 - Verification of orphan-drug status.
§ 316.22 - Permanent-resident agent for foreign sponsor.
§ 316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs.
§ 316.24 - Deficiency letters and granting orphan-drug designation.
§ 316.25 - Refusal to grant orphan-drug designation.
§ 316.26 - Amendment to orphan-drug designation.
§ 316.27 - Change in ownership of orphan-drug designation.
§ 316.28 - Publication of orphan-drug designations.
§ 316.29 - Revocation of orphan-drug designation.
§ 316.30 - Annual reports of holder of orphan-drug designation.
authority:
21 U.S.C. 360aa
,
360bb
,
360cc
,
360dd
,
371
source:
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
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