Staar Will Respond To FDA On “Serious, Continuing Violations”
This article was originally published in The Gray Sheet
Executive Summary
Staar Surgical said it would issue a report to FDA July 15 detailing the firm's plans for resolving a series of quality systems violations
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KCI, Applied Biosystems shuffle: Catherine Burzik becomes CEO of San Antonio-based Kinetic Concepts Nov. 6, succeeding chief executive Denny Ware, who intends to retire at the end of 2006. For the past three years, Burzik led Applied Biosystems, a unit of Applera, as president. She held senior positions at Johnson & Johnson, for a time as president of its Ortho-Clinical Diagnostics business, and Eastman Kodak. Burzik plans to focus on R&D initiatives and expansion of KCI's footprint in international markets. In the wake of Burzik's exit, Tony White, chairman of Applera, will act as interim president of Applied Biosystems until a permanent successor is named...
FDA Issues Resolved, Staar Shoots For Stronger Sales Of Cataract Products
Staar Surgical is committed to restoring domestic cataract product sales in 2006 after putting its regulatory woes to rest during the fourth quarter