FDA May Wield Prosecutorial Authority More Frequently
Device companies can expect more active legal prosecution by FDA for off-label and product safety issues as the agency improves its ability to track products on the market and as the activity of industry whistleblowers grows, according to government and agency staffers
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Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.