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Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...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

Payer Funding Of Interventional Pharmacoeconomic Studies: A New Paradigm

The high cost of pharmaceuticals has provided the stimulus for a new research discipline: interventional pharmacoeconomics. In this discipline, clinical and pharmacological interventions seek to ...
News Medical

Discovering why human intervention studies are essential to human studies

The key legislation covering health claims in Europe is regulation number 1924/2006. Introduced in 2007, this regulation covers all nutrition and health claims made on foods and is overseen by the ...