FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap
Executive Summary
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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Naloxone Model OTC Label Expected From US FDA As Part Of Opioids Strategy
US FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees meet in December to discuss proposed routes to make the opioid overdose reversal agent naloxone more available: both as an OTC product and one co-prescribed with opioids.