21 CFR Part 316 · Orphan Drugs

§ 316.28 Publication of orphan-drug designations

Subpart C - Designation of an Orphan Drug Official text on eCFR Amendment history

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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Amendment history

Federal Register documents that created or amended this section.