Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Legislation

Set Alert for Legislation

Latest From Legislation

Medicare Part D Redesign Will Lead To Bigger Rebate Demands – MedPAC Panelist

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.

Medicare Reimbursement

Six-Month Delay For Russia’s Track And Trace System

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.

Russian Federation Business Strategies

More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions

New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination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.

Regulation FDA

US Drug Pricing Legislation Efforts Headed Toward Spring Renewal? A Look Ahead

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.

Pricing Debate Legislation

European Medicines Agency Restructures To Tackle New Challenges

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. 

Europe Regulation

Queen’s Speech Promises More NHS Spending After Brexit

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.

United Kingdom Brexit
See All
UsernamePublicRestriction

Register