Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with ...

Background: Cognitive impairment is a core feature of schizophrenia, profoundly impacting patients’ functional abilities. As such, evaluating cognition-related functional activity/impairment is ...

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...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