Information request for BLA 125478/0, January 7, 2014 - RAGWITEK

From: Greenfeder, Scott [mailto:scott.greenfeder@merck.com] 
Sent: Tuesday, January 07, 2014 3:20 PM
To: Valenti, Elizabeth
Cc: Rivers, Katie
Subject: RE: Information Request for BLA125478/0

Dear Betsy,
 Attached please find Merck’s response to the below information request.

Regards,
 Scott
Scott Greenfeder, Ph.D.
 Director and Liaison
 Global Regulatory Affairs
 T: +1 732-594-1021
 Fax: +1 732-594-1030
scott.greenfeder@merck.com
 Merck Research Labs
 126 East Lincoln Ave.
 MS RY33-204
 Rahway, NJ 07065 
www.merck.com 


From: Valenti, Elizabeth [mailto:Elizabeth.Valenti@fda.hhs.gov ]
Sent: Tuesday, December 31, 2013 2:27 PM
To: Greenfeder, Scott
Cc: Valenti, Elizabeth; Rivers, Katie
Subject: Information Request for BLA125478/0
 Dear Scott,
 We have the following Information Request (IR) for your BLA, STN 125478/0:
 Please complete the data for the two tables in the attached Excel file.
 Please reply to this IR by Tuesday, January 7, 2014. You may reply via email. Please let me know if you have any questions or would like further clarification.
 Happy New Year, Betsy
Elizabeth J. Valenti, MPH, RAC (U.S.), REHS/RS
 LCDR, USPHS
 Regulatory Project Manager
 FDA/CBER/OVRR/DVRPA
 1401 Rockville Pike
 Mailstop HFM-481
 Rockville, MD 20852
 (301) 796-2640
elizabeth.valenti@fda.hhs.gov

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