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.