21 C.F.R. § 316.24 Granting orphan-drug designation.
Title 21 - Food and Drugs
(a) FDA will grant the request for orphan-drug designation if none of the reasons described in §316.25 for requiring or permitting refusal to grant such a request applies. (b) When a request for orphan-drug designation is granted, FDA will notify the sponsor in writing and will publicize the orphan-drug designation in accordance with §316.28.
Title 21: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart C—Designation of an Orphan Drug
§ 316.24 Granting orphan-drug designation.
