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Vaccines, Blood & Biologics

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Request for information, February 24, 2011 - Laviv

From: Tull, Lori
Sent: Thursday, February 24, 2011 2:34 PM
To: 'Dana Weinberger'
Subject: RE: Request for information

Thanks Dana.

One more issue regarding to that SAE case: We would like the you to provide your rationale as why you consider this SAE (leukocytoclastic vasculitis) is unlikely to be related to the study product.

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: Dana Weinberger [mailto:dweinberger@cbrintl.com]
Sent: Wednesday, February 23, 2011 5:06 PM
To: Tull, Lori
Cc: Dana Weinberger; Jeanne Novak
Subject: RE: Request for information
 

Dear Lori,

Thank you for your request. We are working with the clinical site and hospital to obtain the requested information, and we will provide you with any available information as soon as possible. We currently are expecting to submit available information the week of Feb 28th, and we will keep you posted regarding any change to this timeline.

Please feel free to let us know if you have any questions or requests, or need the information more urgently.

 

Thanks,

Dana

 

Dana A. Weinberger, Ph.D., RAC

Director of Regulatory Affairs

CBR International Corp.®

2905 Wilderness Place Ste. 202

Boulder, CO 80301

(877)270-1345 - Nation-wide Toll Free

720-746-1190 Office

720-746-1192 Fax

www.cbrintl.com

 

This electronic transmission (including any and all attachments) is intended solely for the use of the individual or entity to whom it is addressed and may contain information that is privileged and/or confidential. If you are not the intended recipient of this electronic transmission, you are hereby notified that any disclosure, copying or distribution, or the taking of any action in reliance upon the contents of this electronic transmission, is strictly prohibited, and you are further requested to purge this electronic transmission and all copies thereof from your computer system.

 

From: Tull, Lori [mailto:Lori.Tull@fda.hhs.gov]
Sent: Friday, February 18, 2011 10:19 AM
To: Jeanne Novak
Cc: Dana Weinberger; Kevin Hennegan
Subject: Request for information

 

Hi Jeanne,

 

Dr. Zhu would like to request the following information regarding subject --(b)(6)- who had SAE of leukocytoclastic vasculitis in Study IT-H-001.

(1) full admission history & physical and discharge summary of the July 4 admission;

(2) rheumotoloical and/or dermatological consultation write-ups;

(3) skin biopsy report on the admission;

(4) routine blood work, lab tests, and rhemotological markers during this admission: such as CBC, CMP, UA C&S, CRP, ESR, ANA, ANCA, etc;

(5) clinical follow-up and update on this patient, including any blood work such as CRP/ESR (whether it is normalized)

 

Thank you,

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.