Opioid REMS: New CME 'Blueprint' To Include Immediate-Release Drugs

US FDA is moving forward on two fronts to update and improve the Risk Evaluation & Mitigation Strategy to help limit misuse and abuse of opioid pain medications: the agency has a plan to incorporate IR sponsors into the existing REMS, and also a new 'blueprint' for the prescriber education that focuses on pain management.

The continued debate over how FDA can enhance its response to the opioid abuse epidemic should not distract from the significance of the changes FDA is already moving ahead with in 2017. The largest and most far-reaching post-marketing safety program imposed by the agency is about to get dramatically larger.

Newly installed FDA Commissioner Scott Gottlieb has pledged to make the opioid response his top priority, and is following through by creating a new Opioid Policy Steering Committee at FDA to explore

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