Long-Term Opioid Efficacy Studies Will Take Years, Gottlieb Says
Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.
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Did OxyContin Labeling Change Help Fuel Opioid Epidemic? Republicans Want More Data From FDA
Members of House Energy & Commerce Committee reiterate concerns that 2001 label revision may have been used to help promote higher dosage and longer-term prescriptions of OxyContin. J&J boosts opioid litigation settlement offer to $5bn.
Opioid 'Data Warehouse' Is Part Of US FDA's New Controlled Substances Program
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
Hahn's Priorities For US FDA Eschew Hot-Button Issues, Focus on Traditional Themes
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.