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GUIDANCE DOCUMENT

Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines Guidance for Industry May 2007

Final

Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines

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

This document is intended to provide to you, sponsors of seasonal inactivated influenza vaccines, guidance on clinical development approaches to support a Biologics License Application (BLA). The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based seasonal vaccines, including "split virus," subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. This document does not address live attenuated influenza vaccines or influenza vaccines that do not rely on immunity to a hemagglutinin component.


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