Online Program

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Wednesday, September 25
Wed, Sep 25, 9:45 AM - 10:30 AM
Marriott Foyer
Poster Session

Changes in the Safety and Benefit-Risk Evaluations at FDA in Light of PDUFA VI and the New Drugs Regulatory Program Modernization (300925)

Alexander Cambon, FDA 
Susan P Duke, FDA/CDER/OB 
Jiwei He, FDA 
*Anna Kettermann, FDA 
David Petullo, FDA 
Cesar Torres, FDA 
Jade Wang, FDA 

Keywords: Safety, Benefit-Risk, New Drugs Regulatory Program Modernization, PDUFA VI

Evaluation of pre-market safety, efficacy, and benefit-risk is crucial in regulatory decision making and has often not included a systematic rigorous statistical review and planning. Based on the recent modernization efforts at the FDA and PDUFA VI commitments, the safety and benefit-risk evaluations at FDA are being re-thought. Historically, the approach to evaluation of safety has always been different than evaluation of efficacy because some aspects of safety cannot be pre-specified. Since most key safety endpoints are known a priori (Phase 2 trials, drugs of the same class, etc.), could we develop a more systematic approach to evaluation of safety? The goal of this poster is to discuss the current experience and to identify the next steps in development of a systematic approach to evaluation of pre-market safety and its relationship with efficacy.

Disclaimer: This poster reflects the views of the authors and should not be construed to represent FDA’s views or policies.