OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
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The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.
The move should increase the visibility of the FDA’s wide-ranging, and widely criticized, opioid epidemic response.