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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

Crossref DOI link: https://doi.org/10.1007/s43441-022-00477-y

Published Online: 2022-11-18

Published Print: 2023-03

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Roberts, Scott W. https://orcid.org/0000-0001-8963-3282
Elvang, Tara Laura Brandt

Syed, Laila

Samuelsen, Marianne Bork

Arp-Hansen, Eva Lisby

Nielsen, Henrik Kim

Lund, Ida Katrine

Dünweber, Dorte Lunøe

Listov-Saabye, Nicolai

Bjørn-Larsen, Dorte

Hjelmsmark, Anette

Mikkelsen, Tue Anker
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Text and Data Mining valid from 2022-11-18

Version of Record valid from 2022-11-18
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Article History

Received: 13 June 2022

Accepted: 31 October 2022

First Online: 18 November 2022

Change Date: 6 December 2022

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s43441-022-00487-w

Declarations

:

: The views expressed in this article are those of the authors and do not necessarily reflect the opinions of their companies/institutions. All authors are currently employed by Novo Nordisk.

Updates are available Correction dated 2022-12-06

Click to view Correction: https://doi.org/10.1007/s43441-022-00487-w