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Email - Major Amendment, February 26, 2009 - Adenovirus

Hithe, Darlene

From: Miller, Daryll L
Sent: Thursday, February 26, 2009 3:32 PM
To: 'Pakulski, John' Cc: Hithe, Darlene
Subject: Information regarding the validation of the lyophilization --(b)(4)--

Hi John,

Here is some information for you about two scenarios for the submission of the validation report on the --(b)(4)--  of the lyophilization process from -----(b)(4)------

1. Submission of the validation report in June as mentioned in your January 29. 2009 amendment.  Any amendment with substantive information, submitted to the BLA within 3 months of the Action Due, will be considered a Major Amendment and will add 3 months to the Action Due date. Please see http://www.fda.gov/cber/regsopp/8402.htm.

2. Submission of a supplement after the BLA is approved.  The (b)(4) data will be considered for Action on July 31.  A manufacturing supplement submitted post licensure will likely be considered a Prior Approval Supp with a 4 month review clock

Dr. Gang Wang and I will be discussing your current proposal for providing the validation data and may have more information and possibly a third scenario for you in the near future.  I will be in touch early next week.

Regards, Daryll

Daryll L. Miller, M.A. Regulatory
Health Project Manager
1401 Rockville Pike, Suite 370N
Rockville, MD 20852
Telephone: 301-827-3070 Fax: 301-827-3532