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Nauck MA, Heimesaat MM, Behle K, Holst JJ, Nauck MS, Ritzel R, Hfner M, Schmiegel WH

The FDA has released a series of documents since 2017 detailing how RWE may be used in submissions for medical devices, drugs, and biologics, including its 2018 Framework for Real-World Evidence and more recent guidance on data standards and the evaluation of electronic health record and claims data

Immunological remodeling The immune system typically identifies and destroys cancer cells, while cancer can evade immune detection through immunosuppression