FDA Takes Hard Line On Opioid Class REMS: Cooperate, Or Face Withdrawal
FDA appears to be taking a hard line with drug sponsors on the development of a Risk Evaluation and Mitigation Strategy for extended-release opioids: cooperate on a class REMS, or face a product withdrawal
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Public meeting set for end of May: next step on the difficult road to a class-wide REMS. Important precedent in the making.
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
FDA is starting the process of developing a classwide Risk Evaluation & Mitigation Strategy for potent opioid drug products - with the resulting program expected to be the most extensive REMS required by the agency since the implementation of the FDA Amendments Act