Regulation, regulation, regulation

A BMJ investigation this week raises concerns about the ability of the US Food and Drug Administration to monitor the safety of medical devices through post-approval surveillance. We ask: is the FDA giving device manufacturers an easy regulatory ride? Also, the National Institute for Health and Clinical Excellence (NICE) is set to lose the power to restrict the use of any drug that exceeds its £30k cost per quality adjusted life year ceiling. Alan Maynard, professor of health economics at the University of York, discusses what this will mean.