Class-Wide REMS: "A Self-Propagating Purgatory"

01 Jun 2010

• By Laura Helbling

It hasn't been easy for two dozen companies to work together in trying to craft a viable class-wide risk management program for long-acting opioids. If they are successful, expect FDA to push for more class-wide REMS.

By Laura Helbling

The opioid class-wide Risk Evaluation & Mitigation Strategy poses an unprecedented challenge for industry cooperation among competitors. And, if it...