13 September 2022 - To help better track submissions that include real world data and real world evidence, the US FDA is asking drug and biologics sponsors to indicate the inclusion of such data in their premarket application cover letters.

On 8 September, FDA published a final guidance titled, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products. The draft version of the guidance was published in 2019 and was meant to help clarify the agency’s thinking on how sponsors should summarise their real world data/real world evidence in product applications.

The guidance is the result of the agency’s mandate under the 21st Century Cures Act to develop a real world evidence program to evaluate the use of real world evidence in regulatory decision-making.

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