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Reference Standard - Cervarix, August 31, 2007
From: Sullivan, Helen M
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.