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Kedbumin BLA Question Email, March 14, 2011 - Kedbumin

From: Allard, Crystal
Sent: Monday, March 14, 2011 2:53 PM
To: -----(b)(4)-----
Cc: Kedrion Mail
Subject: RE: KEDBUMIN BLA - Question Please.
Hi (b)(4),

Yes, it is acceptable for Kedrion to submit the information outlined below as an amendment to the original BLA 125384/0.

Best,

Crystal


From: --------------------------(b)(4)----------------------
Sent: Thursday, March 10, 2011 2:28 PM
To: Allard, Crystal
Cc: Kedrion Mail
Subject: KEDBUMIN BLA - Question Please.
Dear Crystal,

Kedrion have requested an answer on the following please:

FDA inspectors have requested to amend some sections of the BLA to give more information on the filling operations description and to remove the -----------(b)(4)------------- (section 3.2.P.3.3), to provide more information and results on the primary packaging material (section 3.2.P.7); and to update the stability data (section 3.2.P.8)

Kedrion would like to implement as soon as possible the following change:-

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

This is an improvement with regards to the segregation of US and non-US products.

Kedrion seek confirmation that this kind of change could be submitted now and l also the sections affected by this change., before the BLA approval as an amendment to the following Table reported in section 3.2.R.2 and 3.2.A.1?

The table is below.

. Table R.2-1.   Manufacturing Steps and Equipment at Kedrion’s Facility

Pages 2 and 3 have been redacted (b)(4)