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GUIDANCE DOCUMENT

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies Guidance for Industry April 1997

Final
Docket Number:
97N-0029
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research (CBER) is providing this document to provide further guidance and advice on the production, testing and clinical study of combination vaccines. A separate section will deal with issues related to simultaneous administration of vaccines. This document does not cover therapeutic combination vaccines. Not all issues outlined in this document will pertain to all types of combination vaccines. For example, some issues related to live vaccines may not apply to inactivated vaccines and vice versa. As with other guidance documents, FDA does not intend this document to be all-inclusive and cautions that not all information may be applicable to all situations. This document is intended to provide information and does not set forth requirements. FDA anticipates that manufacturers may develop alternative methods and procedures, and discuss them with FDA. This guidance document represent the agency's current thinking regarding issues related to combination vaccines. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.


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: 97N-0029.

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