The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...

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 ...

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, ...

Artivion has debuted long-term clinical data on two of its cardiac stent products, revealing each’s solution’s potential to offer extended benefits to patients. This includes one-year data from the ...

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 ...

Objective The aims of this study, which uses a trial within a cohort design, were to determine the efficacy of a web-based intervention to increase moderate-to-vigorous intensity physical activity ...

At U.S. medical schools, interventional radiologists continue to earn more than diagnostic radiologists, though the compensation divide is narrowing, according to a study published Oct. 21 in the ...