Lurie Joins FDA: Critic Of Agency, Industry Will Help Make Regulatory Policy
This article was originally published in The Gray Sheet
Executive Summary
One of the most outspoken critics of the device industry and FDA's device center has been named to a top-level position within the agency
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John Taylor, counselor to FDA Commissioner Margaret Hamburg, will fill the role vacated by Principal Deputy Commissioner Joshua Sharfstein on an acting basis for 60 days and could be well positioned to ultimately take over the job permanently.
Regulatory News In Brief
Stryker resolves another warning letter: The firm has resolved the second of four warning letters received since 2007 related to quality issues, Stryker reported March 23. Following a 2009 re-inspection and further corrective actions, FDA determined the company had sufficiently addressed a November 2007 warning letter for quality system problems at its reconstructive implant manufacturing facility in Mahwah, N.J. No further formal corrective actions are required, Stryker said. Last fall, FDA lifted another of the warning letters, this one for quality system and compliance violations at the orthopedic device maker's biotech division (1"The Gray Sheet" Oct. 26, 2009). Stryker initiated a three-year, roughly $200 million compliance program overhaul in 2008 (2'The Gray Sheet" Feb. 2, 2009)