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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.

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Title: 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.
Authors: Roberts SW; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. osrb@novonordisk.com., Elvang TLB; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Syed L; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Samuelsen MB; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Arp-Hansen EL; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Nielsen HK; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Lund IK; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Dünweber DL; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Listov-Saabye N; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Bjørn-Larsen D; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Hjelmsmark A; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Mikkelsen TA; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Mar; Vol. 57 (2), pp. 386-395. Date of Electronic Publication: 2022 Nov 18.
Publication Type: Journal Article
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
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