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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CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
Promoting innovation, expansion of data use, and patient and consumer empowerment will affect agency work going forward, the FDA Commissioner said in his first all-staff address. Absent from his all-hands memo was drug pricing, opioids, or any other potentially political themes.