Product Approval Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
Division of Vaccines and Related Products Applications
Telecon Memo
| Date: | August 31, 2007 |
| To: | The File of STN 125254 |
| From: | Rakesh Pandey, Ph.D. |
| Sponsor: | CSL Limited. |
| Subject: | Advice telecon for STN: 125254: BLA for Influenza Virus Vaccine, (Afluria®), |
I contacted Paul Hartmann of CSL Behring to ask for clarifications and communicated on the following topics:
- Please clarify whether CSL performed the General Safety test according to 21CFR 610.11a regulation. We asked this since it does appear that they do not use the CFR mandated E2 reference standard for endotoxin.
- I confirmed that CSL was not exempted from General Safety test, and that is why they were doing it in the first place.
- I asked them to clarify the stage at which they do endotoxin testing as it appeared that they did endotoxin testing ---------------------------, however, since CBER does its testing on the final trivalent bulks, did they have endotoxin data at that stage the CBER could use to verify against CBER's results for the endotoxin testing.,
- I told CSL that as we do for others, for CSL also, we are going to release only the trivalent bulk.
- CBER wanted to resolve the issue about E2 and General Safety very soon. It appeared to me that they are doing the CFR mandated General Safety testing on Final Container, and not using the E2 standard and that Endotoxin testing data is provided ---------------------------------- and we wanted it for trivalent bulk to compare our results.