BALTIMORE – Regulators and industry representatives said that a new international guideline for evaluating the benefit-risk profile of new and marketed drugs developed by the Council for International ...

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription ...

This workshop series provided a venue for stakeholders to discuss structured approaches to characterize and communicate the sources of uncertainty in benefit-risk assessment in drug development and ...

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I ...

In a recent study posted to the medRxiv* preprint server, researchers modeled the benefit-risk of Moderna’s coronavirus disease 2019 (COVID-19) mRNA-1273 vaccine. Study: BENEFIT-RISK ASSESSMENT OF ...

Please provide your email address to receive an email when new articles are posted on . FDA panel voted 12-2 against approval for obeticholic acid for pre-cirrhotic patients with liver fibrosis due to ...

Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial We adapted an established ...