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BRIEF-U.S. FDA takes steps to stem opioid misuse and abuse
September 28, 2017 / 8:09 PM / in 21 days

BRIEF-U.S. FDA takes steps to stem opioid misuse and abuse

Sept 28 (Reuters) - U.S. Food and Drug Administration Commissioner Scott Gottlieb:

* U.S. FDA’s Commissioner Gottlieb says this week, issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in outpatient setting‍​

* FDA’s Gottlieb-the letters notified the manufacturers their drugs will be subject to more stringent criteria under a Risk Evaluation, Mitigation Strategy‍​

* ‍FDA’s Gottlieb says the Risk Evaluation and Mitigation Strategy requires that training be made available to health care providers who prescribe IR opioids​

* ‍FDA's Gottlieb-will soon issue guidance for potential applicants who plan to seek approval of generic version of abuse-deterrent formulations of opioid drugs Source text: (bit.ly/2fvipmE)

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