What Influences CDER Advisory Committee Members?

Posted 15 May 2015 By Lara Burgess, PhD, RAC, Virginia Cox, JD, Bert Regeer, MD

placeholder+image Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditionally are required.

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Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Features, US, CDER

Tags: CDER Advisory Committee, Advisory Committee, FDA Advisory Committee, CDER Advisory Panel, Influence

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