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GUIDANCE DOCUMENT

Development of Preventive HIV Vaccines for Use in Pediatric Populations Guidance for Industry May 2006

Final

Development of Preventive HIV Vaccines for Use in Pediatric Populations

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

In this guidance, we, FDA, provide recommendations to sponsors regarding data to support the: 1) Initiation of pediatric studies of a preventive HIV vaccine under a United States (U.S.) investigational new drug application (IND); and 2) licensure of a preventive HIV vaccine for pediatric use. We also provide recommendations to investigators and institutional review boards (IRBs) who are involved with these pediatric studies.


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