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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 316—ORPHAN DRUGS > SUBPART C—Designation of an Orphan Drug (§316.20 to §316.30) > 316.28—Publication of orphan-drug designations.

CFR

316.28—Publication of orphan-drug designations.

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.
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