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| Windhover's FDA/CMS Summit The Food and Drug Administration's approach to drug safety is headed for significant changes in the wake of several high-profile drug withdrawals, critiques of the advisory committee process, and pending legislation to revamp its review procedures. These changes will have a lasting impact on the companies that develop and market regulated drugs. Steven E. Nissen, M.D., FACC, Vice-Chairman of Cardiology, The Cleveland Clinic Foundation, will headline an in-depth discussion of the changes underway and in consideration for the FDA's drug evaluation and safety assessment procedures at Windhover's FDA/CMS Summit. The Summit will take place Dec. 4-5 in Washington, DC. Nissen, a former member of FDA's Cardiovascular and Renal Drugs Advisory Committee and a key figure in the Cleveland Clinic's emergence as a major clinical trials site, is a leading academic advocate for changes in FDA's approach to assessing drug safety. He coauthored an analysis of FDA's review of Bristol-Myers Squibb's Pargluva new drug application that coincided with the agency's decision not to approve the drug. Additionally, Nissen participated in the recent Institute of Medicine review of the U.S. drug safety system, calling for randomized trials when safety signals arise and for FDA to "raise the bar" on approval standards for first-in-class drugs. The summit comes at a watershed point for FDA -- one month after the Congressional elections will usher in a new Congress with an intensified focus on the agency. The FDA/CMS Summit will help pharmaceutical executives identify the issues at stake for the agency and its regulated industry constituents. write your comments about the article :: © 2006 Exhibition News :: home page |