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FDA's WLF Reply Cites Legislative Record As Support For Off-Label Position

This article was originally published in The Gray Sheet

Executive Summary

Judge Royce Lamberth's decision on the off-label dissemination provisions of the FDA Modernization Act should accord "deference" to Congress' careful consideration of "substantial evidence" when crafting the statute, FDA argues in a reply to the Washington Legal Foundation's April 29 brief filed in WLF v. Henney.
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