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Sarah Powell, FRAPS, RAC

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United States

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1 to 2 of 2 total
Posted By Sarah Powell 20-Dec-2012 09:59
Found In Egroup: Regulatory Open Forum
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In response to Michael's poll, I think they have been very careful to word the information as to not state that their product is intended to diagnose either of these conditions. The fact that they direct you to medical informaiton about the conditions is purely educational in nature. I vote for them ...
Posted By Sarah Powell 08-May-2012 05:06
Found In Egroup: Regulatory Open Forum
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Alison, Since 2008, CDER has required that sponsors of new marketing applications (ANDAs, BLAs, NDAs, INDs), and related submissions (master files, advertising material and promotional labeling), including original submissions, supplements, annual reports, and amendments to the applications submitted ...