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Medical & Health initiatives led the way in 2013 at SXSW. But what were missing were Big Pharma and the FDA.The FDA 3 years ago promised guidance on Pharma social practices and 2 years ago promised guidance on Pharma mobile health apps and medical devices. They released preliminary guidance, had a public forum, but never made good on their promise. In the mean time Pharma companies have been trying to couple their drugs with actionable care solutions. The gray area is around patient tracker apps. The original guidance said “anything that helps the doctor make a treatment decision is a medical device”, but the community said, “hold it, how is that different from a paper and pen journal?” The FDA responded at an open forum, yet they never released guidance. So,many pharma companies are afraid of getting a letter. Our discussion will focus on what we can do to improve the submission and approval process of medical apps and devices through the FDA.
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