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Pharmaceuticals / Regulatory Affairs

FDA Looking Into New Review Process for Opioids, Gottlieb Says

Nov. 29, 2018
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FDA Commissioner Scott Gottlieb said the agency is mulling a fresh way of reviewing new opioid drugs before approving them.

Gottlieb said he has asked the agency to consider weighing an opioid product’s risks and benefits against those of already-approved opioids. The FDA now typically evaluates the individual qualities of each new opioid drug submission and whether it meets safety and effectiveness standards.

Under the new framework, the agency would compare the public health implications and potential risks and benefits of new drugs to those of opioids already on the market.

“We should consider whether we could do more to weigh approvals against existing drugs for the treatment of pain — to ensure that new opioid drugs are differentiated from existing drugs, in terms of their overall benefits and risks, to justify their addition to the market in the context of the current crisis,” Gottlieb said, in remarks at a workshop of the National Comprehensive Cancer Network and the American Society of Clinical Oncology.

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