Record of Telephone Conversation, February 24, 2014 - RAGWITEKRECORD OF TELEPHONE CONVERSATION

 Submission Type: BLA Submission ID: 125478/0 Office: OVRR
 Product:
 Short Ragweed Pollen Allergen Extract
 Applicant:
 Merck Sharp & Dohme Corp.
 Telecon Date/Time: 24-Feb-2014 03:30 PM Initiated by FDA? Yes
 Telephone Number: 
 Communication Categorie(s):
 1. Information Request

Author: KATIE RIVERS
 Telecon Summary:
 Request for clarification regarding lot release samples submitted and the treatment packaging configuration. Request for submission of lot release samples for Ragwitek. 
 FDA Participants: Jennifer Bridgewater
 Non-FDA Participants: Scott Greenfeder

Telecon Body:

Ms. Bridgewater requested confirmation regarding the configuration of the treatment packaging for lot release samples. Dr. Greenfeder confirmed that the configuration is 10 tablets per blister pack cartons; each box contains 3 cartoned blister packs. Ms. Bridgewater requested lots in support be submitted for Ragwitek along with the completed lot release protocols. Dr. Greenfeder confirmed that the samples are ready and will be submitted shortly.

The email documented below contains specific details of the Ragwitek lot release samples to be submitted.


From: Bridgewater, Jennifer 
Sent: Monday, February 24, 2014 5:16 PM
To: scott.greenfeder@merck.com
Cc: Rivers, Katie; Valenti, Elizabeth
Subject: RE: Ragwitek Lots in Support

Sorry, I have that incorrect. For each lot of Ragwitek; we need a total of 9 blister packs of 10 tablets each; which is equivalent to 90 tablets. We do not need 120 tablets. Sorry for the error.

Thanks
 Jennifer




From: Bridgewater, Jennifer 
Sent: Monday, February 24, 2014 5:07 PM
To: scott.greenfeder@merck.com
Cc: Rivers, Katie; Valenti, Elizabeth; Bridgewater, Jennifer
Subject: Ragwitek Lots in Support

Dear Scott –

I apologize, I neglected to tell you how many samples to send in. We need the equivalent of 120 tablets. So for Ragwitek that would be 12 blister packs of 10 tablets each. You can select them different parts of the fill; just make sure that we have the total amount of 120 tablets. Also, for both Grastek and Ragwitek, can you please send us the procedure you use for dissolution of the tablets in preparation for –b(4)-- testing? However you dissolve them so that you can run an –b(4)-- please let us know.

Thanks
 Jennifer

Jennifer L. Bridgewater
 Associate Director for Regulatory Policy
 FDA/CBER/OVRR/DBPAP
 301-435-3011
Jennifer.bridgewater@fda.hhs.gov
