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Beware the 'Simple' Path: Combo Drug/Devices Tricky

By Marie Powers
Staff Writer

Thursday, April 11, 2013
Pity the poor drug developer that thinks using the combination drug/device regulatory pathway through the FDA's Office of Combination Products could be a shortcut to approval, bypassing the sometimes unpredictable regulatory oversight of the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research.

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