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Real-World Data Can Include EUA Observations, US FDA Final Guidance Says

 
• By Bridget Silverman

Agency clarifies expectations for non-interventional studies providing RWD to support regulatory decisions while continuing to emphasize familiar themes around early interaction and stringent data practices.

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• Source: Shutterstock

An explicit statement that data collected from clinical practice with products available under an emergency use authorization (EUA) can be considered in the scope of real-word data is one of the clarifications made by the US FDA in its final guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.”

The final guidance published 31 August 2023 edits and clarifies the draft version issued on 9 December 2021 as part...

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