US FDA's Words Matter: Sharpless Says Injectable Naloxone OK For Community Distribution
The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.
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The move should increase the visibility of the FDA’s wide-ranging, and widely criticized, opioid epidemic response.
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.