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Information Request Email, May 7, 2012 - ALLOCORD

From: Donna Regan [dregan@slcbb.org]
Sent: Monday, May 07, 2012 4:42 PM
To: Tull, Lori
Subject: RE: CMC information request

Hello Lori,

 

Our response to Dr Ghosh?s question:

 

Table 10, a part of BL 125413/0, Serial Number 06 Attachment D (not B)

 

This work was done in the initial studies, and the table entries are primarily based on use of ------(b)(4)-------- medium.  The two exceptions in the table are the testing of --------------------------(b)(4)-------------------------------, which were tested in ----(b)(4)---- medium.  The results of the growth in -------(b)(4)------- media are included in the validation as informational but not essential to the validation, and therefore, when our later focus shifted to use of ----(b)(4)---- medium and growth in --(b)(4)-- media only, these trials were not repeated with use of the ---(b)(4)--- medium. 

 

All of the data included in Tables 11 and 12, which summarize our data related to sensitivity, specificity and reproducibility, is collected from trials done with ---(b)(4)--- medium.

 

The label, ---(b)(4)--- in Attachment B, the raw data summary from our validation of the --(b)(4)--, when followed by an asterisk, denotes the use of ----(b)(4)---- as the ---(b)(4)--- blood culture medium in the trial.  In the absence of an asterisk, ---(b)(4)--- indicates the use of ---(b)(4)--- medium, except in the case of a study done once for each ---------(b)(4)-------- organism in which a direct comparison of the time-to-detection of the two types of --(b)(4)-- culture media was conducted.  In these cases, ---(b)(4)--- is followed by and the data separated into -----(b)(4)-----.

 

Respectfully,

 

Donna M. Regan, MT(ASCP)SBB
Executive Director
St. Louis Cord Blood Bank & Cellular Therapy Laboratory
@ SSM Cardinal Glennon Children's Medical Center
3662 Park Avenue
St. Louis, MO  63110
ph  314-268-2700 ext 6313
dregan@slcbb.org
www.slcbb.org

 

 

 

From: Tull, Lori [mailto:Lori.Tull@fda.hhs.gov]
Sent: Monday, May 07, 2012 8:50 AM
To: Donna Regan
Subject: FW: CMC information request

 

Hi Donna, 

 

Joy had one question regarding this information:

 

1. Ref - Table 10 from Attachment B of BL 125413/0, Serial Number 06: Were all "---(b)(4)---" tests listed under this table done using the ------(b)(4)------- medium?

 

Thanks,

Lori

Lori A. Tull, RAC

Regulatory Project Manager

Office of Cellular, Tissue, and Gene Therapies

Center for Biologics Evaluation and Research

(301) 827-5359

 

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.

 


--------------------------------------------------------------------------------

From: Donna Regan [mailto:dregan@slcbb.org]  
Sent: Wednesday, May 02, 2012 8:52 AM
To: Tull, Lori
Subject: RE: CMC information request

Hi Lori ?

 

Attached you?ll find our response to Dr Ghosh?s questions.  Please let me know if you require this response to be more formal.

 

Thank you ? Donna

 

From: Tull, Lori [mailto:Lori.Tull@fda.hhs.gov]
Sent: Thursday, April 19, 2012 12:56 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)----------------------------"?

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

 

 

Lori A. Tull, RAC

Regulatory Project Manager

Office of Cellular, Tissue, and Gene Therapies

Center for Biologics Evaluation and Research

(301) 827-5359

 

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.