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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request - Provenge, March 22, 2007

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research


March 22, 2007

SPONSOR:                Dendreon Corporation
PRODUCT:                 Sipuleucel-T
TO:                         File STN 125197/0
FROM:                     Gang Wang, Ph.D., CBER/OCBQ/DMPQ/MRB II, HFM-675
SUBJECT:                 Information Request


Connie Spooner, Sr. Manager for Regulatory Affair at Dendreon called me this noon. She told me that due to their busy schedules in preparing next week’s advisory committee (AC) meeting, they will submit the information about the Aseptic Process Validation for Module b(4) and the multiple product issues that I requested at last Friday’s weekly joint meeting between CBER and Dendreon a week after the AC meeting to be held next Thursday. I agreed. She wanted to make sure that the information submitted would not be considered as a major amendment, and I told her that it would not be considered as a major amendment because we had already reviewed the information during the PLI, and the requested information should be a part of BLA and be included. Laurie Norwood confirmed my answer after the telecon.
I asked Ms. Spooner to provide me some information on the history of New Jersey manufacturing facility to be included in EIR, and she agreed.
This concludes the telecon.
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