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§ 316.28 - Publication of orphan-drug designations.

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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:

The name and address of the sponsor;

The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;

The date of the granting of orphan-drug designation;

The designated use in the rare disease or condition; and

If the drug loses designation after August 12, 2013, the date of it no longer having designation.

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§ 316.27 - Change in ownership of orphan-drug designation.
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§ 316.29 - Revocation of orphan-drug designation.