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FDA Stresses Science-Based Compliance and Open Communication

Mon, 04/20/2009 - 13:49
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(FDA: Salt Lake City)—Utah-based life science companies are being implored to utilize a scientific approach to regulatory compliance, and to keep the lines of communication open with the Food and Drug Administration. FDA district director Tom Warwick recently spoke with hundreds of life-science professionals during a special lunch meeting hosted by the Utah Technology Council (UTC) and Intermountain Biomedical Association (IBA). Warwick heads the Denver office of the FDA, which covers Utah and other surrounding states.

Warwick answered questions and concerns from the more than 300 life-science professionals in attendance. The majority of the questions were directed at FDA inspections and the FDA’s plan for 2009. “Our inspectors are taught to be professional, open, and transparent,” said Warwick. “Our goal is to develop respectful relationships with the companies we inspect.”

Warwick also spoke about the work plan for FDA in coming years, and the significant increase in staffing over the past two years because of new legislation and Congressional mandates. With increased staffing, food safety will be a major focus both domestically and internationally.

 …

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