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Vaccines, Blood & Biologics

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Vaccines

Email - Stability Data, May 1, 2009 - Adenovirus

From:                     Miller, Daryll L
Sent:                      Friday, May 01, 2009 3:34 PM
To:                         'Pakulski, John'; -----(b)(6)------
Cc:                         Hithe, Darlene
Subject:                 Stability Data

Hi --(b)(6)-- and John,

I have been going through the materials that were provided to me by you and your colleagues and cannot seem to find something. I know that you provided me some stability updates but all I have are updates for the intermediate product. Did you give me the update for the tablet stability? The original submission only covered the stability up to 18 months.

Whether you have provided it yet or not, please include it with the stability on the intermediate as an amendment to the BLA as soon as possible.  If we do not have this information, we cannot approve 24 months dating on the vaccine.

One more thing, John.  Has everyone at Barr been given secure e-mail with CBER?  If not, please make sure that nothing that you consider proprietary is sent to us by someone who does not have secure e-mail.  Everything that CBER sends to you is secure but your communications to us are only secure if you have a specific secure account.

Regards, Daryll

Daryll L. Miller, MA
Regulatory Project Manager
FDA\CBER\OVRR\DVRPA
1401 Rockville Pike, Suite 370 N
Rockville, MD 20852
Phone: 301-827-3070
Fax:      301-827-3532

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