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Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...
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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...
The National Law Review

FDA: New Guidance for Non-interventional Studies of Drug Safety and Effectiveness

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
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Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with ...
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The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission.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 ...
ascopubs.org

CaboCombo: A prospective international non-interventional study of first-line cabozantinib plus nivolumab for the treatment of patients with advanced renal cell carcinoma.

Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma (ODYSSEY RCC). This is an ASCO Meeting Abstract from the 2023 ASCO Genitourinary Cancers Symposium.
ascopubs.org

CARINA interim analysis: A non-interventional study of real-world treatment sequencing and outcomes in patients with advanced renal cell carcinoma initiated on first-line ...

Clinical outcomes of patients with metastatic renal cell carcinoma who discontinued nivolumab +/- ipilimumab therapy electively or due to toxicity. This is an ASCO Meeting Abstract from the 2023 ASCO ...