§316.28. Publication of orphan-drug designations. — Inbound Citations
21 C.F.R. § 316.28
Statutory Authority
Cited by 3 regulations in release Current.
Citations to 21 C.F.R. § 316.28 as a whole
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(c) 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.
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(d) In accordance with § 316.28, FDA will make a cumulative list of all orphan drug designations available to the public and update such list monthly.
Citations to §316.28(e)
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(d) If FDA revokes orphan-drug designation, FDA will publicize that the drug is no longer designated in accordance with § 316.28(e).