Opioid Policy At US FDA To Become 'More Forceful,' Gottlieb Says
Whether to require physician education, when to limit the doses prescribed to patients, and how to weigh societal abuse potential in approvals are the initial questions for the Opioid Policy Steering Committee.
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Opioids: FDA Actions May Silence Call For Moratorium On Approvals
Citizen petition seeks review of all marketed opioids; agency is considering whether new opioids should have comparative benefit over existing drugs.
Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory
FDA has always described its role as stopping short of regulating the practice of medicine. When it comes to opioids, that is no longer the case.
Opioid REMS Hearing Features Top-Level FDA Team – But No Manufacturers
FDA’s most recent public meeting to explore better approaches to managing prescription opioids marked the public debut of its new Opioid Steering Committee. The issue has top management attention at FDA – but the hearing didn’t include any industry speakers.