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In Brief: National uniformity legislation

This article was originally published in The Rose Sheet

Executive Summary

National uniformity legislation: Rep. Richard Burr's (R-N.C.) HR 1411, introduced April 23, includes national uniformity language that prohibits states from enacting any requirement inconsistent with the federal Public Health Service Act or the Fair Packaging and Labeling Act, including any "notification requirement for a drug or cosmetic that provides for a warning concerning the safety of the drug or cosmetic or any component or package thereof." The "Drug and Biological Products Modernization Act," which remains virtually unchanged from a July discussion draft, updates Burr's HR 3199 introduced in the 105th session. A House hearing on FDA reform April 23 primarily discussed changes to the pharmaceutical regulatory system and the prescription drug user fee act. Another reform hearing in the Senate focusing on medical device issues has been scheduled for April 30...
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