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"Voluntary Education Does Not Work"

 
• By Cole Werble

A lot of people spent a lot of time at FDA working on a proposal for a class-wide opioid REMS: at least 70 people worked on the project over the past 18 months. When an FDA advisory committee considered the plan, though, a very brief statement by a former committee chair may have helped undo a lot of that work.

At least 70 Food & Drug Administration employees worked on the development of a proposed class-wide REMS for the long-acting opioid class. Two dozen pharmaceutical companies have been working in parallel trying to shape the proposal and provide input to the agency.

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