US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework
Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.
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Real-World Evidence, Digital Health, Insurance Coverage Reforms On Cures 2.0 Agenda
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.