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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 316 - Orphan Drugs |
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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. |