Publication of orphan-drug designations.

21 C.F.R. § 316.28
in effectEffective: 2024-07-01
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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.

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