FDA Commissioner Gottlieb is proposing that the agency approve new opioid painkillers only if they show comparative advantages over existing drugs
WASHINGTON—Food and Drug Administration Commissioner Scott Gottlieb is proposing that the agency take the novel step of approving new opioid painkillers only if they show comparative advantages over existing drugs in reducing pain or enhancing safety.
Dr. Gottlieb, in remarks before a Senate Appropriations subcommittee, suggested Thursday that the FDA create a new and restricted standard of approving opioids in response to the addiction crisis gripping the U.S. The agency has been under pressure to take stronger action, including...
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