The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...

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, ...

The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission.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 ...

Clinical trials are well-controlled and designed experiments that aim to prove that an Investigational Medicinal Product (IMP) is effective. Clinical trial data is submitted to the national health ...

MENLO PARK, Calif.--(BUSINESS WIRE)--GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced final results from the interventional PATHFINDER ...