Liability unleashed? US FDA generics labeling proposal could mean lawsuits ahead

This article was originally published in SRA

12 Nov 2013
News

Donna Young @ScripDonnaDC Donna.young@informa.com

Executive Summary

A proposal by the US Food and Drug Administration to allow generic drug makers to independently update their product labeling with newly-acquired safety information before regulators review those changes^1,2 could expose those manufacturers to liability when patients have adverse reactions – something those companies currently are protected against under two rulings by the Supreme Court.

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Liability unleashed? US FDA generics labeling proposal could mean lawsuits ahead

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