The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...

The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission.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

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 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, ...

The International Council on Harmonisation (ICH) announced on Friday the adoption of its M14 guideline, which aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies ...

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 ...

Background Hearing loss (HL) imposes a substantial burden on families and society and is the largest modifiable risk factor for dementia. As a practical and non-invasive approach to managing HL, ...