January 24, 2022. Although well-designed RWD and RWE studies can provide useful information about drug safety and even effectiveness, there are major shortcomings if RWD and RWE studies replace rather than supplement data from well-designed clinical trials. We therefore strongly encourage the FDA to make it clear that studies based on RWE should only be considered to provide supplemental evidence that can support regulatory decision-making for drugs and biological products.
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