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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.
Ther Innov Regul Sci. 2023 Mar;57(2):386-395. doi: 10.1007/s43441-022-00477-y. Epub 2022 Nov 18.
Ther Innov Regul Sci. 2023.
PMID: 36401076
Correction: 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.
Roberts SW, et al. Among authors: hjelmsmark a.
Ther Innov Regul Sci. 2023 Mar;57(2):396-398. doi: 10.1007/s43441-022-00487-w.
Ther Innov Regul Sci. 2023.
PMID: 36472778
No abstract available.
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