21 C.F.R. § 316.28 Publication of orphan-drug designations.
Title 21 - Food and Drugs
Each month FDA will update a publically available list of drugs designated as orphan drugs. A cumulative, updated list of all designated drugs will be provided annually. These will be placed on file at the FDA Division of Dockets Management, and will contain the following information: (a) The name and address of the manufacturer and sponsor; (b) The generic name and trade name, if any, of the drug and the date of the granting of orphan-drug designation; (c) The rare disease or condition for which orphan-drug designation was granted; and (d) The proposed indication for use of the drug.
Title 21: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart C—Designation of an Orphan Drug
§ 316.28 Publication of orphan-drug designations.
