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

Background Despite calls for the use of additional real-world evidence (RWE) during drug development, rates of inclusion at the regulatory stage remain low. The medicine adoption model suggests that providing additional RWE to regulators would result in a wider indicated population than providing ra...

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Main Author: Ravi Jandhyala (Author)
Format: Book
Published: Taylor & Francis Group, 2022-12-01T00:00:00Z.
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3rd Floor Main Library

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Call Number: A1234.567
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