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GUIDANCE DOCUMENT

General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases Guidance for Industry December 2011

Final

General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases

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

In this guidance, we, FDA (or the Agency), provide information to assist sponsors in developing vaccines to protect against global infectious diseases. The guidance will focus on development and licensure of vaccines targeted against infectious diseases or conditions endemic in areas outside the United States (U.S.). In addition, the guidance will clarify regulations, statutes and guidances applicable to the development of these products.


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