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