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Growing Pains For US FDA Oversight Of Opioids: Starting Over On Assessment Of REMS

Executive Summary

Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.

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Opioid Prescriber Education Program May Become Mandatory; FDA Cites Failures In Voluntary System

US regulators set public workshop on benefits, challenges, and unintended consequences of making REMS education program mandatory. Having a single source for education is also being evaluated. Agency has previously been concerned that a mandatory program might require a restricted distribution system.

Campaign Against Woodcock’s US FDA Commissioner Bid Has Begun

Opioid issues delayed Robert Califf’s confirmation as FDA commissioner. Could they prevent the nomination of Janet Woodcock?

Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.

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