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.
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| Title: | 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. |
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| 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. 396-398. |
| Publication Type: | Published Erratum |
| Journal Info: | Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE; PubMed not MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 36472778 AccessLevel: 2 PubTypeId: unknown PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Roberts+SW%22">Roberts SW</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. osrb@novonordisk.com.<br /><searchLink fieldCode="AU" term="%22Elvang+TLB%22">Elvang TLB</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Syed+L%22">Syed L</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Samuelsen+MB%22">Samuelsen MB</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Arp-Hansen+EL%22">Arp-Hansen EL</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Nielsen+HK%22">Nielsen HK</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Lund+IK%22">Lund IK</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Dünweber+DL%22">Dünweber DL</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Listov-Saabye+N%22">Listov-Saabye N</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Bjørn-Larsen+D%22">Bjørn-Larsen D</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Hjelmsmark+A%22">Hjelmsmark A</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Mikkelsen+TA%22">Mikkelsen TA</searchLink>; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101597411%22">Therapeutic innovation & regulatory science</searchLink> [Ther Innov Regul Sci] 2023 Mar; Vol. 57 (2), pp. 396-398. – Name: TypePub Label: Publication Type Group: TypPub Data: Published Erratum – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer+International+Publishing%22">Springer International Publishing </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101597411 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>2168-4804 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221684790%22">21684790 </searchLink><i>NLM ISO Abbreviation: </i>Ther Innov Regul Sci <i>Subsets: </i>MEDLINE; PubMed not MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=36472778 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s43441-022-00487-w Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 396 Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Roberts SW – PersonEntity: Name: NameFull: Elvang TLB – PersonEntity: Name: NameFull: Syed L – PersonEntity: Name: NameFull: Samuelsen MB – PersonEntity: Name: NameFull: Arp-Hansen EL – PersonEntity: Name: NameFull: Nielsen HK – PersonEntity: Name: NameFull: Lund IK – PersonEntity: Name: NameFull: Dünweber DL – PersonEntity: Name: NameFull: Listov-Saabye N – PersonEntity: Name: NameFull: Bjørn-Larsen D – PersonEntity: Name: NameFull: Hjelmsmark A – PersonEntity: Name: NameFull: Mikkelsen TA IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 03 Text: 2023 Mar Type: published Y: 2023 Identifiers: – Type: issn-electronic Value: 2168-4804 Numbering: – Type: volume Value: 57 – Type: issue Value: 2 Titles: – TitleFull: Therapeutic innovation & regulatory science Type: main |
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