What is the FDA requirement for long-term evaluations of the prescriber training component of the ER/LA Opioid Analgesics REMS?

The FDA has required long-term evaluations of the ER/LA prescribers who complete REMS-compliant CE activities. Specifically, the FDA is requiring the evaluation of knowledge retention and practice change in ER/LA opioid prescribers 6-12 months after completing the REMS-compliant CE activity. The long-term evaluations will be separate and different from any post-tests that might be conducted by accredited CE providers immediately after all REMS-compliant CE activities.