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)--
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.
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