Public Meeting to Address FDA’s Benefit-Risk Assessments
The US Food and Drug Administration (FDA) on Tuesday announced it will hold a public meeting on 16 May to evaluate ways to apply FDA’s benefit-risk framework throughout the human drug lifecycle and the best approaches to communicating FDA’s benefit-risk assessment.After gathering industry, patient, researcher and other stakeholders’ input, the agency said it will draft a guidance document in FY 2020 on benefit-risk assessment for new drugs and biologics. The meeting will be convened by Duke University’s Robert J. Margolis Center for Health Policy (Duke-Margolis).
According to Duke-Margolis, which will also create a publicly available summary report, the meeting will address: “1) FDA’s planned benefit-risk assessment guidance; 2) activities that occur in pre-market development that best inform FDA’s benefit-risk assessment; 3) effectively communicating benefit-risk assessment information; and 4) using benefit-risk assessment to inform FDA and sponsor decision-making in the post-marketing setting.”
The meeting, which is intended to satisfy a goal of the latest PDUFA reauthorization, will “allow participants (including industry, patients, researchers, and other stakeholders) to provide input on key topics, including the application of FDA’s Benefit-Risk Framework throughout the human drug lifecycle and information that sponsors may develop or collect at the various stages of drug development that can inform the benefit-risk assessment and related regulatory decisions,” FDA added.
The meeting will also discuss how relevant patient experience data may inform the benefit-risk assessments and appropriate approaches to communicate to the public FDA’s thinking regarding a product’s benefit-risk assessment.
Registration must be completed by 10 May.
Federal Register