Systematic Risk Assessment for Risk-Based Monitoring
Risk Management, RMPs, and REMS
FDA Benefit-Risk Framework
What is FDA Benefit-Risk Framework?The FDA Benefit-Risk Framework is an enhanced, structured, systematic approach to benefit-risk assessment in regulatory decision-making for human drug and biologic products. This framework was developed through extensive review and analysis of previous and ongoing regulatory decisions. The main goals of this initiative are:
- To be clearer and more consistent in communicating the reasoning behind drug regulatory decisions, including which benefits and risks are considered, how the evidence is interpreted and what the implications of the evidence are for the benefit-risk assessment.
- To ensure that the FDA reviewers’ detailed assessments can be readily placed in the larger patient care and public health context.
When would I need to use FDA Benefit-Risk Framework?The FDA Benefit-Risk Framework is an internal requirement of FDA reviewers, so there is no regulatory requirement for sponsors to use the framework. However, an emerging best practice of leading sponsors is to use the framework as a way to understand how an FDA reviewer will perceive the benefit-risk profile of an investigational or marketed product. In this best practice, sponsors should perform a benefit-risk assessment for every product at every decision point at every stage of the product life cycle. Benefit-risk assessment should start early in the clinical development process and continue through the post-marketing timeframe.
What are the benefits of doing FDA Benefit-Risk Framework?Using the FDA Benefit-Risk Framework provides:
- A systematic approach to organizing the information that FDA reviewers are seeking regarding the benefit-risk profile of the product and a principled approach to benefit-risk assessment that is generally aligned with other global initiatives
- A common ground to facilitate and improve communication and transparency between the sponsor and the FDA regarding benefit-risk assessment during the drug development and review cycles
- Evidence for the product’s risk management plan
- An opportunity to gain group consensus regarding the elements of the benefit-risk assessment
- A document that can be updated and utilized throughout the product life cycle