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By Erin O'Brien

February 18, 2014

Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent paper, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska  offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur.  In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.