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Health IT Now Pushes Gottlieb On 21st Century Cures Priorities

August 11, 2017
FDA should implement a risk-based approach to health technologies that meet the definition of medical devices, further clarify how real-world evidence (RWE) can be used by industry, and include predictive pre-clinical testing in its discussion of novel trial designs, Health IT Now (HITN) argues in a letter to FDA Commissioner Scott Gottlieb outlining the group's priorities for 21st Century Cures implementation. HITN, a coalition of patient groups, health care provider organizations, employers and payers, calls on FDA to set forth...

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