The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission.
The draft guidance is one of several guidance documents the agency has issued on the use of real-world data and evidence (RWD/RWE) in regulatory decision making. In August 2023, FDA issued final guidance related to data access and safety monitoring considerations for RWD/RWE, particularly non-interventional clinical study designs. (RELATED: FDA finalizes guidance on real-world evidence in drug approvals, Regulatory Focus 31 August 2023)
“The reliability and relevance of real-world data (RWD) used in a non-interventional study are critical for making appropriate causal inferences and are essential to establishing the data’s fitness for use in generating real-world evidence to support a labeling change or address a safety concern,” FDA wrote in the latest draft guidance…
