Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies. - Roberts SW; Elvang TLB; Syed L; Samuelsen MB; Arp-Hansen EL; Nielsen HK; Lund IK; Dünweber DL; Listov-Saabye N; Bjørn-Larsen D; Hjelmsmark A; Mikkelsen TA (Therapeutic innovation & regulatory science, 2023)