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GUIDANCE DOCUMENT

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

Final
Docket Number:
2004D-0414
Issued by:
Guidance Issuing Office
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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010