§316.25. Refusal to grant orphan-drug designation. — Inbound Citations
21 C.F.R. § 316.25
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 316.25 as a whole
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(b) 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.