Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro is the featured presenter in a 90-minute webinar hosted by Elsevier Business Intelligence, titled “Discover the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance.” The webinar is scheduled for June 19, 2012 at 1:00 PM (Eastern).
During the webinar, Mr. Shapiro will delve into FDA’s recently issued final guidance document, “Factors to Consider When Making Benefit-Risk Determination in Medical Device Premarket Approval and De Novo Classifications” (see our previous post here). This first-of-its-kind guidance document outlines the systematic approach FDA device reviewers will take when making risk-benefit determinations. According to FDA Center for Devices and Radiological Health Director Jeffrey Shuren, the final guidance “clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations.”
During the webinar, Mr. Shapiro will take a critical look at the new final risk-benefit guidance, explain which aspects of this guidance are actually old news and which ones may move FDA decision making in a new direction, and discuss how the guidance has affected research and development programs as well as clinical data requirements. To register for the webinar click here.