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Dingell bill seeks US generic user fees for pre-approval inspections

This article was originally published in Scrip

Executive Summary

Three US Democratic lawmakers on the House energy and commerce committee, including Representative John Dingell, have introduced a revised version of a 2008 draft food and safety bill that aims to strengthen theFDA's regulatory powers and shore up its overseas inspections through new industry user fees. The bill follows the same broad scope as outlined last year, but in a first, the bill would require user fees from generics firms for pre-approval inspections for generic drugs.




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