What do you believe that the fda was justified

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Reference no: EM133333078

Question: Do you believe that the FDA was justified in issuing a Warning Letter to the manufacturer for their promotion of Toujeo? With respect to the Tuojeo marketing material(s) do you believe that the manufacturer presented a fair balance of the risk vs. the benefits that accompany clinical utilization of the product based on substantial clinical evidence of safety and effectiveness for the products approved indication(s) for use? Are the promotional materials misleading? If so, how can the material be (re) written or otherwise modified to present a more balanced overview to consumers about the benefits associated with using the product?

Reference no: EM133333078

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