Long-Acting Opioid REMS Tally: FDA Lists 12 Brand, 23 Generic
Nineteen companies will implement individual Risk Evaluation and Mitigation Strategies for long-acting/extended-release opioid products that are subject to the class-wide REMS unveiled by FDA July 9.
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.