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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.
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. 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. 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.
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
Algorri M, Acharya A, Bernstein J, Cauchon NS, Chen XH, Huynh-Ba K, Krantz C, Li T, Li Y, McLamore S, Roberts SW, Schwinke D, Shah R, Schirmer A, Strickland H, Tang K, Watson T. Algorri M, et al. Among authors: roberts sw. AAPS Open. 2022;8(1):19. doi: 10.1186/s41120-022-00066-1. Epub 2022 Dec 5. AAPS Open. 2022. PMID: 36530577 Free PMC article.
77 results