In regulatory news:

Top officials from the FDA recently announced the need for a “far-reaching action plan to reassess the agency’s approach to opioid medications.” As part of its focus on opioid policies, the FDA has stated these objectives, among others:

  • Re-examine the “risk–benefit paradigm” for opioids and their wider public health effects.
  • Convene an independent expert advisory committee composed of pain management and drug abuse experts before approving new drug applications for opioids without abuse-deterrent properties.
  • Develop changes to immediate-release opioid labeling.
  • Strengthen requirements for drug companies regarding postmarketing data on the long-term impact of their extended-release/long-acting opioids.
  • Expand access to abuse-deterrent formulations of opioid products, naloxone and medication-assisted treatment options.

Read more about the FDA plan via Pain Medicine News here.

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