Information Request for BLA125478/0, February 27, 2014 - Ragwitek

From: Rivers, Katie
Sent: Thursday, February 27, 2014 12:38 PM
To: 'Greenfeder, Scott'
Cc: Valenti, Elizabeth; Bridgewater, Jennifer; Vaillancourt, Julienne
Subject: RE: Question regarding RAGWITEK CMC

Dear Scott,
 We have reviewed your January 14, 2014, amendment to BLA 125478/0. We note that the –b(4)--------------------------------- specifications were established based on evaluation of only –b(4)-- unexpired batches; ---b(4)------------------------------------------------------------. The specifications generated from these –b(4)----batches are slightly wider in comparison to the specifications obtained from evaluation of all expired and unexpired batches (-b(4--). Considering that you had only –b(4)-- batches for statistical analysis we agree to your proposed –b(4)--------------------------------------------------------------- as an initial specification for licensure. However, we request that you submit a formal Postmarketing Commitment (PMC) to your BLA to re-evaluate and revise if necessary the –b(4)-- limits and corresponding –b(4)-- after manufacture of multiple lots post approval. In your PMC you should specify: the number of lots you propose to collect, a time frame for collection of data on those lots, and a time frame for submission of the data for review. Please submit a draft PMC by email for our review and comment.

In addition to the above, we agree that the –b(4)--- method may be used as final product release test for measuring –b(4)- as required by –b(4)----

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
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From: Greenfeder, Scott [mailto:scott.greenfeder@merck.com ]
Sent: Wednesday, February 19, 2014 8:16 AM
To: Rivers, Katie
Cc: Valenti, Elizabeth
Subject: Question regarding RAGWITEK CMC

Dear Katie,
 We are finalizing the LRP’s now for Ragwitek for which –b(4)---------------------specs will be included. Is CBER in agreement with the –b(4)---------------------- limits proposed in our response submitted on Jan 14,2014 to the IR of Dec. 19th, 2013?

In the response submitted on Jan 14, 2014 we requested concurrence with the use of the –b(4)---- method for measuring –b(4)-- and the specifications 
 (modified ---b(4)-------------------------------------------------------------------) using the –b(4)-------------------------

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 
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