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Latest From Legislation
DeRoyal’s DeBusk urges a focus on rebates, while Brookings' Ginsburg wants a focus on design, not savings per se, as MedPAC discusses restructuring the Part D design to better accommodate current market dynamics. Formal recommendations to Congress may be approved in the spring.
Russia’s new drug traceability system won’t now be implemented until July, but companies that are ready and able are being encouraged to put the system through its paces in order to flush out any glitches.
New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.
Senate legislation taking aim at price increases faces uphill climb, but sponsors are hoping President Trump will mobilize more support among congressional Republicans in the coming year.
A restructuring involving the setting up of four new task forces is aimed at improving how the European Medicines Agency responds to issues such as permanent staff reductions and challenges in regulatory science, digital business transformation, and clinical trial strategy.
The new UK government’s political priorities for the years ahead were laid out in the 19 December Queen’s speech, which inevitably centred around the UK’s departure from the EU next month and the negotiation of a free trade deal with the EU. A rise in NHS spending was promised, and new legislation on the future of medicines regulation is on the horizon.
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