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doi: 10.1053/j.gastro.2011.02.054 57 JavedMAWenLAwaisMLatawiecDHuangWChvanovMet al

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With injectable therapeutic doses, the exposure to the infant may be higher, and the need for such treatment must be clearly established

We proposed at 428.401(d)(2)(ii) that for a circumstance in which a manufacturer misreports data, CMS will not bound by the 5-year time limit for revision of the rebate amount

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