JD Supra

Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...
RAPS

Stakeholders request elaboration, consistency in FDA’s non-interventional RWE studies guidance

Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with ...
JD Supra

FDA advises on RWE non-interventional study use as evidence of effectiveness or safety

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...
RAPS

Euro Roundup: EMA shares draft paper on non-interventional studies using RWD

The European Medicines Agency (EMA) is seeking feedback on non-interventional studies (NIS) that use real-world data (RWD) for regulatory purposes. In the draft reflection paper, EMA defines a NIS as ...