21 CFR 316.28 - Publication of orphan-drug designations.

§ 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]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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