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FDA finalizes guidance on oversight of RWE studies, making several significant changes

The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence. While the FDA mostly ignored suggestions from more than two dozen companies and trade groups, it managed to make several significant changes to the guidance that seem to solve one major problem and create a potentially costly new oversight burden on life sciences companies.

Regulatory background

Quick Background: Real-world Data (RWD) and evidence (RWE). In medical product research, RWD is considered any data captured outside of the confines of a clinical trial, such as claims or electronic health record (EHR) data or records from clinical registries, while RWE is evidence generated from analyzing those data.

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