Early Preparation, Now More Than Ever, is Key to Successful FDA Device Panel Meetings
Sponsors need to understand the changes in FDA’s Draft Guidance for Medical Devices Advisory Committees, and its implications, to better prepare for product approval. The April 2nd issue of The Gray Sheet featured a guest column from 3D Communications’ Amy Tezel, PhD and Chris Miller, MS. The article discusses how Sponsors can anticipate likely panel issues well before the PMA submission, and proactively engage with FDA, early and consistently throughout the development program. The column is an adaptation from this White Paper.
ABOUT THE AUTHORS
Chris Miller, MS is a biostatistician who brings experience in the design, analysis, and interpretation of clinical trials to 3D clients. As a senior project manager, Chris leverages statistical expertise with excellent communications skills to integrate complex data with key messages. Connect with Chris on LinkedIn.
Amy Tezel, PhD, combines her extensive scientific background, regulatory experience across the entire FDA approval process, and an ability to communicate effectively to prepare clients for success. Amy’s experience in medical devices spans from pre-IDE, IDE, and PMA preparations to FDA advisory committee meetings and post-approval commitment negotiations. Amy is a former 3D employee, now at Alcon.
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