The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, ...

A novel collaboration may establish a framework to help researchers overcome regulatory barriers they often face when ...

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Thrive Earlier Detection Corp., a company dedicated to extending and saving lives by incorporating earlier cancer detection into routine medical care, together with ...

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 ...