Benefit Risk from a Regulatory Perspective
*Joyce Korvick, FDA 


The use of frameworks in semi-quantitative, structured analyses during the regulatory decision making process may be useful throughout the therapeutic product life-cycle. A unified evaluation of benefits and risks during the product life-cycle presents challenges. In order to increase transparency during consideration of the benefits and risks of a biomedical therapy, a more systematic presentation of clinical trial and postmarket data is necessary. Elements and structure of such a framework will be discussed, as well as the potential usefulness in regulatory decision making.