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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...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Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...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

Interventional Analytics in Skilled Nursing Facilities Associated With Reduced Readmissions

A retrospective analysis of 30-day risk-adjusted readmission rates among skilled nursing facilities (SNFs) between 2017 and 2022 compared those that had implemented an interventional analytics ...
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 ...
ascopubs.org

An interventional study of the impact of digital patient monitoring (DPM) on health outcomes, healthcare resource utilization, and feasibility of a combination with at-home ...

Liquid biopsy-informed precision oncology study to evaluate utility of plasma genomic profiling for therapy selection. This is an ASCO Meeting Abstract from the 2023 ASCO Annual Meeting I. This ...
Medical News Today

Understanding the different types of medical research studies

Medical research is essential for advancing the understanding of health, diseases, and treatments. There are many types of studies that serve different purposes. Medical research, or health research, ...