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US report finds FDA staff disagreed with pre-emption views

This article was originally published in Scrip

Executive Summary

Career staff in the US FDA's drugs centre disagreed with pre-emption language in a 2006 agency rule revising the content and format of professional labelling, but their views were over-ridden by political appointees, a congressional report found. Drugs centre officials also questioned the rationale behind a recent rule restricting the types of labelling changes that can be made through a "changes being effected" (CBE) supplement without prior approval, saying the measure could discourage companies from quickly adding necessary warnings to drug labels.



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