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

GUIDANCE DOCUMENT

• Docket Number: FDA-1997-N-0454
• Issued by: 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.

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