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Home » FDA Mandates Postmarket Studies, Label Changes for ER/LA Opioid Painkillers
FDA Mandates Postmarket Studies, Label Changes for ER/LA Opioid Painkillers
September 10, 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 Tuesday.