The new FDA Commissioner says “It’ all about the pain”

NEW FDA COMMISSIONER: “IT’S ABOUT THE PAIN” (Orthopedics This Week) If you're in the business or profession of addressing pain, you've got the attention of the new FDA Commissioner, Robert Califf, M.D. On March 30, 2016, Califf wrote in his first agency blog posting that the agency has an overarching "clear, realistic, and focused sense of priorities," with pain and the "present epidemic of opioid overdose" a specific critical issue on his front burner. The Commissioner writes that the vast of majority of decisions made by the agency are made possible by "a system sustained by professionalism and a well-earned reputation for high-quality and impartial judgments—despite the fact that many decisions must ultimately disappoint (or at least not fully satisfy) one or more constituencies." He notes that dramatic advances in biotechnology and information sciences, as well as continuously accelerating trends toward globalization, are ushering in an era of rapid change. High Quality Evidence "We must do everything possible to rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances. What does this mean?...


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