The US FDA’s enthusiasm for the mandatory Risk Evaluation & Mitigation Strategies authority appears to have hit a new low, based on the agency’s approach during its three January advisory committee meetings.
US FDA’s REMS Reluctance On Display At Recent Advisory Committees
Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.
More from Drug Safety
More from Pink Sheet
• By
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.
• By
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.
• By
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.