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The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency

Crossref DOI link: https://doi.org/10.1186/s40545-022-00433-z

Published Online: 2022-05-04

Published Print: 2022-12

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

Authors

Jandhyala, Ravi https://orcid.org/0000-0002-7241-7476
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Text and Data Mining valid from 2022-05-04

Version of Record valid from 2022-05-04
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Article History

Received: 20 April 2022

Accepted: 23 April 2022

First Online: 4 May 2022

Declarations

:

: Ethics approval and consent to participate were not applicable.

: Not applicable.

: The author is the founder and CEO of Medialis Ltd, a medical affairs consultancy and contract research organisation involved in the design and delivery of real-world evidence including the patient-reported outcomes and patient registries.

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