Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018

@article{Heyward2020KeyES,
  title={Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018},
  author={James Heyward and T. J. Moore and Jennifer Chen and Kristin Meek and P. Lurie and G. Alexander},
  journal={Annals of Internal Medicine},
  year={2020},
  volume={173},
  pages={956 - 963}
}
BACKGROUND Little is known about the evidence required by the U.S. Food and Drug Administration (FDA) for new approvals of opioid analgesics. OBJECTIVE To characterize the quality of safety and efficacy data in new drug applications (NDAs) for opioid analgesics approved by the FDA between 1997 and 2018. DESIGN Cross-sectional analysis. SETTING Data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications. PARTICIPANTS Patients with pain who participated in phase 3 pivotal… Expand

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