Going Around in Circles
This article was originally published in RPM Report
Early on in the committee discussion of Acurox, FDA made its feelings about the product clear. Here is a transcript of the exchange between two committee members and two FDA officials on the key question about the King application: what exactly should be required to allow inclusion of niacin in the formulation with the goal of provoking adverse effects in abusers of immediate release oxycodone.
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