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Vaccines, Blood & Biologics

11/6/2007 Email - Rotarix

From: Henchal, Laraine

Sent: Tuesday, November 06, 2007 2:55 PM

To: ''

Cc: Vujcic, Luba

Subject: STN #125265 Rota BLA Information Request

Hi Donna,

We are requesting that the following items be submitted to your BLA as an amendment to your pending STN:

1) Final Statistical Analysis Plans for studies 023, 033, 036 and 060.

2) Monographs 4063, dated 19 Mar 03 and 3370, dated 24 Feb 03.

3) Full text of all study reports submitted in Annex 2 from module 3.2.S.2.3. consisting of testing conducted on Working Virus Seed --------. We note that only the first page of the reports are provided. In addition, this request would include any other instances of testing performed on other key materials such as cell banks and virus harvests for production of vaccine which may appear in "Control of Materials" and other sections of the Quality Module. It is critical that the full reports for all such testing be submitted to the BLA.

Thank you,
Laraine S. Henchal, MAS, Chair of Review Committee
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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