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Code of Federal Regulations (Last Updated: July 5, 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 |
§ 316.28 - Publication of orphan-drug designations.
Latest version.
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§ 316.28 Publication of orphan-drug designations.
Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information:
(a) The name and address of the sponsor;
(b) The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;
(c) The date of the granting of orphan-drug designation;
(d) The designated use in the rare disease or condition; and
(e) If the drug loses designation after August 12, 2013, the date of it no longer having designation.
[78 FR 35134, June 12, 2013]