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Home » FDA Mandates Postmarket Studies, Label Changes for ER/LA Opioids
FDA Mandates Postmarket Studies, Label Changes for ER/LA Opioids
September 13, 2013
Drugmakers with FDA-approved NDAs for extended-release and long-acting (ER/LA) opioid painkillers will be required to conduct postmarketing studies to help the agency better understand the “epidemic” of abuse and misuse of the drugs, FDA Commissioner Margaret Hamburg said Sept. 10.