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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