Comments on the FDA’s Draft Guidance on Updating Generic Drug Labeling After The Marketing Application For The Reference Listed Drug Has Been Withdrawn

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The draft guidance is a small step toward filling the safety gap that exists because generic drug manufacturers lack authority to initiate labeling changes based on new safety information. To more fully address the problem, we urge the Food and Drug Administration (FDA) to move promptly to finalize the November 2013 proposed rule entitled “Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products.”

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