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Vaccines, Blood & Biologics

3/31/2008 Email - Rotarix

From: Henchal, Laraine
Sent: Monday, March 31, 2008 1:37 PM
To: ''
Subject: Potency release spec

Yes, looks like we will have release potency between ------- (including those values; so ---------------------------------------------------------- at release). End-expiry OK at ---, but with a 24 month dating period for now. With the drop-off on the numbers at -- months, we would like to see further stability data -------------------------------, which can be done with supplement. 24 months may even be enough for you ------------------------------------------------------... So the release criteria will need to be reflected in an amended lot release protocol...I know that Joe Quander had some format questions for you earlier.

Laraine S. Henchal, MAS
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



From: []
Sent: Monday, March 31, 2008 11:58 AM
To: Henchal, Laraine
Subject: welcome back


Hope you had a nice you have any updates regarding the potency spec for me?

best regards,

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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