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

This article was originally published in The Gray Sheet

Executive Summary

"The Gray Sheet" offerings that captured the most Web traffic last month centered on FDA investigator compliance tips, robotic surgery, user fee reauthorization and congressional action, among other topics.

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Abbott Submits PMA For Absorb Bioresorbable Scaffold

The firm's FDA submission for the first-in-class bioresorbable vascular scaffold was completed in the second quarter, a spokesman said. That appears to be ahead of a prior estimate to submit by the end of 2015.

Senate Bill Aimed At Streamlining Combo Product Regulation

A Senate bill would streamline device/drug combination registrations at FDA by letting the agency rely on prior PMAs and approved drug findings to help support new product approvals, among other reforms. It was introduced by Sen. Johnny Isakson, R-Ga., and co-sponsored by Sens. Robert Casey, D-Pa., and Pat Roberts, R-Kansas.

Calls For More FDA Training In Lead Up To User-Fee Negotiations

Device firms will be pushing for more reviewer consistency and to avoid a major increase in fees during upcoming negotiations with FDA to reauthorize the Medical Device User Fee Act. The MDUFA IV reauthorization process starts as Congress is already considering major regulatory reforms and will finish under a new administration in the White House.

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