EMA - Publication of the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application
Year: 2024
Type: other
Abstract: Following a public consultation, the Methodology Working Party (MWP) has finalised the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation. The reflection paper discusses key issues and requirements for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU). More information on the EMA Website.
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12jhq
Author: Vroby
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6917887744
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