Beware the 'Simple' Path: Combo Drug/Devices Tricky
By Marie Powers
Friday, April 12, 2013
Pity the poor drug developer that thinks using the combination drug/device regulatory pathway through the FDA's Office of Combination Products (OCP) could be a shortcut to approval, bypassing the sometimes unpredictable regulatory oversight of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
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