With increasing concerns about the US Food & Drug Administration (FDA) review process and its impact on innovation in the obesity arena, members of academia and industry are working with the FDA to identify best practices for clinical trials and help standardize the clinical investigation and review process. As part of this initiative, the FDA, [Massachusetts General Hospital] (MGH), and Dartmouth College are sponsoring a much anticipated public meeting and workshop in October 2011 that will focus on delineating best practices for clinical trials in the field of bariatrics. To find out more, Medtech Insight interviewed one of the meeting co-directors, Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at MGH, in Boston. According to Kaplan, patient need in the obesity field is "enormous and generally unmet," so it is important for the field to "adopt strategies that will facilitate bringing new, effective therapies to market."
Q:Medtech Insight: How has academia been working with the FDA in terms of improving the FDA review process for weight loss devices?