FDA Kicks Off Opioid Class REMS Discussion; Asks For Industry Collaboration
FDA laid out general guidelines for a class-wide Risk Evaluation and Mitigation Strategy for opioid pain products during a closed-door meeting March 3, and urged manufacturers to work collaboratively to help develop a proposal as soon as possible
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In NEJM editorial, FDA's Woodcock suggests "unintended consequences" of any risk management plan for the pain products.
Drug makers have agreed on communications, education components of strategy.
Public meeting set for end of May: next step on the difficult road to a class-wide REMS. Important precedent in the making.