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February 18, 2014

Drug Shortages in Generic Injectables: Solving the Quality Issue

Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult.&nbsp;In a recent&nbsp;<a href="http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html"><span style="color: #0000ff; text-decoration: underline;">paper</span></a>, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska&nbsp;&nbsp;offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur.&nbsp;&nbsp;In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
Erin O'Brien

Erin O'Brien

Sr. Director, Marketing, Vial Containment


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