FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information Guidance for Industry October 2004

GUIDANCE DOCUMENT

• Docket Number: 2004D-0414
• Issued by: Center for Biologics Evaluation and Research

This guidance document is meant to inform you, vaccine manufacturers, medical practitioners, and consumers, of the type of data that we, FDA, examine when determining the adequacy of vaccine labeling1 by providing an overview of the vaccine labeling review process and describing our review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act (NCVIA).2 The processes described herein represent current FDA practices and do not represent any new interpretation of existing labeling statutes, regulations, or guidances.

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All written comments should be identified with this document's docket number: 2004D-0414.

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