By Michael McCaughan
Who says you can't have your cake and eat it too?
Regulatory Alchemy: The Transformative Power of the Opioid REMS
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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.
Learn what's happening at the US FDA. On the go.
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