Issue Date: October 1, 2004
Issued by: Center for Biologics Evaluation and Research
Topic(s): Pediatric Product Development, Vaccines
Status: Final
FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry
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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