FDA Wants Fast Turnaround In Assessing Opioid REMS' Effectiveness
The agency tells companies to submit proposals in 120 days, and expects to have the REMS in place by the beginning of 2012. The first assessment would be due at six months.
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Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.