TL58: Strategic Issues in Meeting Cardiovascular Risk Assessment Requirements for Diabetes Drug Development
*Shailaja Suryawanshi, Merck & Co., Inc.  


The FDA guidance on evaluating cardiovascular risk in new antidiabetic therapies to treat Type 2 Diabetes raises many issues around the size, conduct and strategic placement of such studies in the drug development program. Some of these issues have to be weighed against ex-US filings where the guidance on CV risk assessment may not be as clear. The discussion will attempt to identify these, summarize the ways in which they are being addressed based on publicly available knowledge and brainstorm on potential solutions.