Opioid Prescribing Guidelines From US FDA Could Be A While After NASEM Report
National Academies report identifies gaps in the existing data – including on the question of whether developing prescribing guidelines would even have an impact on the opioid epidemic.
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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.
A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.