Progress on the Development of a Benefit/Risk Framework for Evaluating Medicines

| 01 March 2010

Determining the benefit/risk (BR) balance of a new medicine is one of the most important steps in its development, review and postapproval reassessment. Recently, regulatory agencies and sponsors have begun to develop appropriate benefit/risk frameworks (BRFs) that enable collaborative scientific discussion of a product's therapeutic profile. Despite these early steps, there is room for improving communications among regulatory agencies and industry stakeholders. Specifically, there remains a need for clear, concise and unambiguous communication of findings about benefits and risks. The CMR International Institute for Regulatory Science (the Institute) recently convened a workshop to address the issues of improving communications regarding BR assessments within and across regional agencies and industry organizations.


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