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Use of RWD and RWE to Support Regulatory Decision Making

Real-World Data (RWD) is being increasingly utilized in clinical research to help support drug approvals. The U.S. Food and Drug Administration (FDA) guidance on Considerations for the Use of Real-World Data and Real-World Evidence (RWE) to Support Regulatory Decision-Making for Drug and Biological Products provides thoughtful recommendations on the use of RWE to support approval of a new indication for marketed drugs. This guidance is part of the FDAs Real-World Evidence Program which provides additional guidance for the use of RWE to support regulatory decisions.