Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
§ 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]
source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.
cite as: 21 CFR 316.28