Information request for BLA 125478/0, December 13, 2013 - RAGWITEK

(System Info - 258536 RIVERS KATIE 12/18/2013 10:47:02 RIVERSK)

From: Rivers, Katie 
Sent: Friday, December 13, 2013 11:58 AM
To: 'Greenfeder, Scott'
Cc: Valenti, Elizabeth
Subject: Information request for BLA125478/0

Dear Scott, 
We have the following information request for your BLAs, STN125478/0:

Please submit a copy of the diary card and subject comment card used for each of the clinical studies.

Please submit this information to your BLA as soon as possible.

Please let me know if you have any questions.

Thank you,


Katie
Katie H. Rivers, M.S.
Regulatory Project Manager, CMC1
FDA/CBER/OVRR/DVRPA
1401 Rockville Pike, HFM-481
Rockville, MD 20852
Phone 301-796-2640
Fax 301-827-3532
