
Regulatory Authority Council (RAC) Letter - Q-Pan

 

 
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service



Food and Drug Administration
 1401 Rockville Pike
 Rockville, MD 20852-1448

Our STN: BL 125419/0

ID Biomedical Corporation of Quebec 
 (dba GlaxoSmithKline Biologicals)
 Attention: Michael Schwartz, Ph.D.
 2301 Renaissance Boulevard, 
 P.O. Box 61540
 King or Prussia, PA 19406-2772

Dear Dr. Schwartz:

We have received your May 24, 2013, resubmission to your biologics license application for Influenza A (H5N1) Virus Monovalent Vaccine for active immunization for the prevention of disease in persons 18years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine, on May 24, 2013

We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is November 23, 2013.

If you have any questions, please contact the Regulatory Project Managers, LCDR Jeremy Wally, Ph.D. or Kirk Prutzman, Ph.D., at (301) 796-2640.

Sincerely yours,

Wellington Sun, M.D.
 Director
 Division of Vaccines and
 Related Product Applications
 Office of Vaccines
 Research and Review
 Center for Biologics
 Evaluation and Research
