Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions

Nov 08, 2021

Posted by Sidley Austin

Real-world data (RWD), data generated by patients and doctors outside of clinical trials, are increasingly being used by the U.S. Food and Drug Administration (FDA) and life sciences companies to support a range of regulatory decisions.

In the U.S., the FDA has had a congressional mandate to advance the regulation of RWD for some years, since the 21st Century Cures Act 2016 set up a framework for how the agency would make more use of RWD in regulatory decisions. Continue reading

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