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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
To properly inform the choices that are made by patients and prescribing physicians, clear 2 descriptions of the effects of a medicine should be available. These descriptions are complicated by the different ways in which each individual patient responds to treatment. Some subjects will tolerate a medicine and adhere to its administration schedule, others will not. Some subjects will require changes in dose of concomitant medication or administration 6 of additional medication, others will not. Multiple ways to quantify treatment effects can be envisaged based on how to take into account, for example, tolerability, adherence and whether or not additional medication is required. Without a precise understanding of the treatment effect that is being described, there is a risk that its magnitude and meaningfulness will be misunderstood.
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All written comments should be identified with this document's docket number: FDA-2017-D-6113.