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Re-inspection fees

This article was originally published in The Gray Sheet

Executive Summary

The new user fee request included in FDA's FY 2007 budget proposal requiring device and drug makers to pay for re-inspections of facilities that fail to comply with good manufacturing practices would not only allow FDA to make the best use of its limited resources, but it would encourage device firms to be in compliance, according to Steven Niedelman, the agency's assistant commissioner for regulatory affairs (1"The Gray Sheet" Feb. 13, 2006, p. 6). "Every time we have to do a re-inspection, we don't get to another [firm] that needs [primary inspection]," Niedelman said in an interview. FDA is interested in hearing from stakeholders on the issue, he said. In Feb. 16 written testimony to the House Appropriations subcommittee overseeing FDA funding, AdvaMed said that "any additional fees must be...associated with clearly identified increased performance to benefit the fee payer above and beyond current performance"...
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