21 CFR 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.
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 316 after this date.