Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?
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The disclosure requirement to participate includes an option for the US FDA to include the ideas on new regulatory uses for real-world evidence in a guidance or speak about them at public forums in order to ‘promote innovation.’
The EU is taking steps to establish a more consistent and standardized approach to the quality of data used in medicines regulation to support benefit-risk decisions.
EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.