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FDA Moves to 'Jump-Start' Over-the-Counter Opioid Antidotes

Monday, January 28, 2019 | 0

The Food and Drug Administration is taking steps to encourage the development of over-the-counter versions of naloxone, an antidote for opioid overdose. Before submitting an application for a new over-the-counter drug, companies must develop a consumer-friendly drug facts label. They must also conduct studies to show that consumers can understand how to use the product without the supervision of a health care professional. Creating and testing the drug facts label has been identified as a hurdle to developing over-the-counter naloxone products, so the FDA took what it called an unprecedented...

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