FDA approved opioids based on limited data, sometimes ‘flawed’ trial designs

The FDA has often approved new drug applications for opioids based on trials of inadequate length that included only patients who could tolerate the drugs, according to researchers.“Despite the scope of America’s ongoing opioid epidemic, little is known regarding the FDA’s approval of new opioid products over the past 2 decades,” G. Caleb Alexander, MD, MS, professor at the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health, told Healio Primary Care. “We examined one important facet of opioid regulation: how high a barRead More

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