RAPS

FDA offers guidance on observational studies as RWE

The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission. The draft ...
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Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with ...