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Sen. Kennedy’s Foreign Inspection Bill Gives FDA More Flexibility Than House

This article was originally published in The Tan Sheet

Executive Summary

House and Senate Democrats are taking similar approaches to invigorate FDA's ability to oversee foreign manufacturing facilities. Some fundamental differences and Republican concerns, however, suggest the issue will likely not be resolved until at least the next Congress

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A senior drug company officer or director would be required to certify the veracity of product applications and safety submissions to FDA under Sens. Edward Kennedy and Chuck Grassley's bill to improve safety in global drug manufacturing and distribution

Senate Bill Adds Criminal Liability To Global Drug Safety Enforcement

A senior drug company officer or director would be required to certify the veracity of product applications and safety submissions to FDA under Sens. Edward Kennedy and Chuck Grassley's bill to improve safety in global drug manufacturing and distribution

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