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Vaccines, Blood & Biologics

CMC Information Request, April 19, 2012 - ALLOCORD


(System Info - 210850 TULL LORI 08/23/2012 14:07:23 TULL)
From:        Tull, Lori
Sent:          Thursday, April 19, 2012 1:56 PM
To:             'Donna Regan'
Subject:     CMC information request
Hi Donna,
Dr. Joydeep Ghosh has the following requests for information regarding your April 6 emailed response:
1. Attachment B: Under Column heading "Sample Type" - what is the difference between "--------------------(b)(4)-----------------" vs "---------------------(b)(4)----------------"?
2. Attachment D: There are two types of ---(b)(4)--- media - "----------------------------------------------(b)(4)---------------------------------" - please clarify i) which one was used for the assay described under Table 10 and ii) which one will be used for testing the sterility of the future licensed product?

Best Regards,
Lori A. Tull, RAC
Regulatory Project Manager
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
(301) 827-5359
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