Characterizing the Food and Drug Administration's Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle; Public Meeting; Request for Comments

Streszczenie

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Characterizing FDA's Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle" and an opportunity for public comment. The meeting will be convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, researcher, and other stakeholder input on applying FDA's Benefit-Risk Framework throughout the human drug lifecycle and best approaches to communicating FDA's benefit-risk assessment. Input from this meeting will support development of a draft guidance on benefit-risk assessment for new drugs and biologics and result in a publicly available summary report from Duke-Margolis. This meeting is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).