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FDA Electronic "Structured Product Labeling" Deadline Pushed Back To Summer 2005

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA had been planning to process SPL through an automated system starting in January 2005. The transition to the structured product labeling format will be neither costly nor difficult for industry, the agency says.

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The final guidance provides three resources companies can access for assistance with SPL. FDA expects label changes for approved drugs will be submitted electronically using SPL by fall; the agency has not yet established a timeframe for unapproved drug labels.

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