§ 316.28. Publication of orphan-drug designations.
101 words·~1 min read·
/us/cfr/t21/s§ 316.28·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]