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21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
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Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.
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]