Product Approval Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Memorandum
| Date: | August 10, 2007 |
| To: | Rakesh Pandey Ph.D. OVRR/DVRPA/VVB HFM-478 |
| From: | Alfred V. Del Grosso Ph.D. HFM-406 OVRR/DPQ/PQLS Nora M. Etz , HFM-406 OVRR/DPQ/PQLS |
| Through: | Rajesh Gupta, Ph.D. HFM-407 OVRR/DPQ/PQLS |
| Subject: | CSL Limited Influenza Virus Vaccine (Afluria TM) STN: 125254/0 Review of Chemical Analytical Procedures |
Review Summary: We have reviewed the following analytical procedures and associated validation studies submitted in the CMC section of this application.
Analytical Procedures:
QA6657 Taurodeoxycholate by -----
QA5030 Thimerosal by --------------------
QA6211 Thimerosal by ------------------------------------
QA5930 pH
QA6699 ------------------------------------------------------------
QA5567 Protein by -----------------------
The following questions should be asked of the manufacturer and commitments should be made prior to licensure:
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