As the title suggests, the PBRER is an evaluation of the benefits of the product against the risks to ensure that the benefit-to-risk ratio is still positive for the product.

In a clinical trial environment, risk-benefit analysis is the comparison of the risk of harm to subjects in relation to the potential benefits. A clinical trial can only be classified as ethical if ...

This article summarizes the provisions of the final 2026 HHS Notice of Benefit Payment Parameters related to the individual ...