January 23, 2006

FDA Calls for Preemption of State Product Liability Claims in Final Rule on Prescription Drug Labeling

Arnold & Porter Advisory

On January 18, 2006, the Food and Drug Administration ("FDA") finalized its long-pending rule revising the format and content requirements for prescription drug labeling, often referred to as the "package insert."1 The new rule, which also applies to most biologics, is intended to make it easier for health care practitioners to access, read, and use information in the package insert by eliminating unnecessary language, highlighting key safety and effectiveness information, and organizing the information in a more useful manner.


Robert N. Weiner
Robert N. Weiner
Senior Counsel
Washington, DC
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