Regulatory Alchemy: The Transformative Power of the Opioid REMS

The three-year long process towards a class-wide Risk Evaluation & Mitigation Strategy has been anything but straightforward. Still, the final twist may be the most surprising: FDA is now espousing the most industry-friendly approach on the table. The details of the opioid REMS will take months to work out and years to judge, but understanding the choices made in crafting this policy are a critical starting point.