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In Case You Missed It: Top 10 "Gray Sheet" Stories In January

This article was originally published in The Gray Sheet

Executive Summary

Our most popular content in January included exclusive analyses of 2015 FDA recalls, warning letters and approvals; business and legal news from Boston Scientific and Johnson & Johnson; a look at combination product reform efforts in the US; plans to improve postmarket surveillance in Europe; and more.

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Europe Readies For Big Changes In Device Postmarket Surveillance

Europe may be on the cusp of a big drive toward a more clearly organized and more transparent postmarket vigilance system with new funds directed at the issue in the wake of device safety scandals. The European Commission recently launched the second phase of its joint action plan of near-term device and diagnostics reforms, pushing postmarket surveillance to the top of its agenda.

FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?

Approvals of PMAs and panel-track supplements, as well as de novo devices, hit a 15-year high in calendar year 2015, according to a "Gray Sheet" analysis. FDA and industry experts respond to the data; also, check out our infographic of 2015 FDA approval trends, including a tally of the firms that captured the most PMAs and 510(k)s last year, and more.

2016 Will Be A Big Year For Combo Product Reform, FDA Says

The agency has already signaled its plan to propose a new statutory pathway for combination products by the end of next year. In the meantime, it's working on a bevy of process changes, guidance documents and rules to enhance premarket and postmarket regulation of combination products in the years ahead. Office of Combination Products officials John Weiner and Thinh Nguyen weigh in.





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