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Vaccines, Blood & Biologics
From: Thompson, Edward
Sent: Friday, November 30, 2012 2:26 PM
To: 'Smyth, Kevin R'
Cc: Ovanesov, Mikhail V.; Drews, Roman T; Campbell, Karen M
Subject: Request for Drug Product Conformance Lot Samples to Original BL 125446/0
Attachments: Licensing Sample template letter doc (2).doc; _Lot Release Protocol Template Basic(newer) pdf.pdf
Dear Mr. Smyth:
We are reviewing your August 28, 2012 biologics license application (BLA) for Coagulation Factor IX (Recombinant). We are requesting additional information to continue our review:
1. Please submit b(4) samples each of the drug product conformance lots –b(4)------------------------------------------------ to the following address:
Regulatory Coordinator (DBSQC)
Building B - Room 2410
5516 Nicholson Lane
Kensington, MD 20895
Please contact Karen via email at email@example.com or via telephone at 301-594-6255 prior to sample submission to alert CBER that the samples are being sent. The samples should be accompanied by a Letter for Licensing Sample Submission, and their respective Lot Release Protocols. Templates of the Letter and Lot Release Protocol are enclosed for your reference.
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.
Please submit your responses to this information request by December 15, 2012 referencing the date of this request. Please email me when you have shipped these samples. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
The action due date for this file is June 30, 2013.
If you have any questions, please contact me.
Edward M. Thompson
Regulatory Project Manager
Office of Blood Research and Review
Division of Blood Applications
301-827-9167, Fax 301-827-2857
1401 Rockville Pike, Room 554N
Rockville, MD 20852-1448
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If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying or other action based on the content of this communication is not authorized. If you have received this document in error, please notify us immediately by telephone and return it to us at the above address by mail. Thank you.