An FDA study on expanding access to opioid overdose-reversal medication could suggest a model for Rx-to-OTC switch proposals that include some form of extra-label information, though the agency isn't going so far as saying the results will facilitate approvals for more nonprescription ingredients.
FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap
CDER has been studying ideas such as pictograms to communicate instructions on administering opioid-reversal medication, but officials can’t predict when new approaches might help enable FDA to propose regulatory changes in the US switch process.
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