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GUIDANCE DOCUMENT

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product Guidance for Industry January 1999

Final

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In the Federal Register of July 8, 1997, the Food and Drug Administration announced the availability of Revised Form FDA 356h, "Application to Market a New Drug, Biologic, or an Antibiotic for Human Use.” This document provides guidance on the content and format of the Chemistry, Manufacturing, and Controls (CMC) and Establishment Description sections of a License Application for a vaccine or related product. Reagents for in vitro diagnostic use are outside the scope of this document


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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