Speeches & Communication

PhRMA Comments on FDA Benefit Risk Assessment

PhRMA Comments on FDA Benefit Risk Assessment

PhRMA May 9, 2013

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the Food and Drug Administration’s (FDA) request for comments on its Draft PDUFA V Implementation Plan: Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making dated February 2013. PhRMA is a voluntary, non-profit association that represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA members invested approximately $50 billion in 2012 in discovering and developing new medicines, representing the vast majority of private investment in new medicines in the United States. PhRMA member companies are committed to the development of innovative, life-saving and life-altering treatments and cures for serious and life-threatening conditions. To that end, PhRMA applauds FDA’s effort in developing this implementation plan and for advancing progress against this important PDUFA V performance goal.

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