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CMC related PMCs for Bivigam Email, December 03, 2012 - Bivigam

From: Kennedy, Michael
Sent: Monday, December 03, 2012 4:08 PM
To: Rana, Pratibha; Norton, Malgorzata; Virata, Maria Luisa; Scott,
Dorothy
Subject: FW: CMC related PMCs for Bivigam

Biotest has agreed to all the CMC PMCs - see below
 

Michael C. Kennedy PhD
Laboratory of Plasma Derivatives
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research

-----Original Message-----
From: Gary Ingenito [mailto:GIngenito@biotestpharma.com]
Sent: Monday, December 03, 2012 3:57 PM
To: Kennedy, Michael
Subject: CMC related PMCs for Bivigam

Michael,

I have placed responses below each item, in parentheses. Please let me know if this is what you were looking for, or what else you would like. If I have misunderstood, please give me a call to discuss.

Best,
Gary
Cell: ----(b)(6)-----

-----Original Message-----
From: Kennedy, Michael [mailto:Michael.Kennedy@fda.hhs.gov]
Sent: Monday, December 03, 2012 9:18 AM
To: Gary Ingenito
Subject: CMC related PMCs for Bivigam

Gary,

There were a number of CMC related PMCs from the first round of review. I think they were communicated to you (except for the first one) but were not officially acknowledged because of the CR Letter. I think some of these have been addressed over the interim. Could you tell me which of these have been addressed and how?

1.-----------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
---(b)(4)----

2.-----------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------(b)(4)---------------------------

3.-------------------------------------------------------(b)(4)----------------------------------------
--------------------------(b)(4)--------------------
 

4.-----------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
---------------------------------------(b)(4)-------------------------------

5.-----------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------(b)(4)-------------------------------
 

6.-----------------------------------------------------------------------------(b)(4)------------------------------------------------------------
----------------------------(b)(4)-------------------------------

7.-----------------------------------------------------------------------------(b)(4)------------------------------------------------------------
-------------------------------------(b)(4)----------------------------------------------

8.-----------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------
 

Thanks,

Michael

 

Michael C. Kennedy PhD
Laboratory of Plasma Derivatives
Division of Hematology
Office of Blood Research and Review