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Vaccines, Blood & Biologics

Request for Information Email, February 18, 2011 - Laviv

From:        Tull, Lori
Sent:          Friday, February 18, 2011 12:19 PM
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 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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