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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Reference Standard - Cervarix, August 31, 2007

From: Sullivan, Helen M
To: "Matt.Whitman@gsk.com";
CC: Subject:
Cervarix RE: Reference Standard
Date: Friday, August 31, 2007 10:40:04 AM


Please submit all characterization and validation data before the reference standard is used as part of your QC testing. This information can be submitted to the BLA or as a PAS following licensure, depending on timing of when the information is available and when you intend to use the new standard.