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IQWiG sees far less promise in other RWE sources such as electronic medicalrecords and billing records of insurers. The registry study will presumably feed into the longer-term assessment of additional benefit, expected in 2027. The results of this won’t come out until November 2021 and will be seen as provisional.
FDA believes that RWE has the power to “accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them, without compromising patient safety.” Every use of ESD is recorded, as is every behavior that falls within the intended use.
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