Information Request Email, July 16, 2012 - EVARREST
From: Tilghman, Tracy
Sent: Monday, July 16, 2012 4:58 PM
To: 'Dauria, Raina [ETHUS]'
Cc: 'Chung, Jessica [ETHUS]'; Shields, Mark
Subject: Reference BL# 125392/0 - Information Request
Attachments: Fibrin Pad BLA 125392 BRP Draft Revised_NA_TL.docx
Dear Ms. Dauria,
We are reviewing your March 30, 2012 resubmission for Fibrin Pad to be used as an adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, and (non-cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical. We request the following information below to continue our review:
1. Please submit a revised version of the Lot Release Protocol in an amendment to the BLA 125392/0 to reflect the following changes:
-The license number is 1879;
-Sections on Sterility testing and Endotoxin testing are re-instated as they should be part of the
Lot Release Protocol;
-"Fibrin Sealant Patch" is used as the proper name for your product at this time, and may be changed when a consensus between Ethicon/Omrix and FDA is reached;
-Editorial changes to improve clarity.
2. Please submit, in an amendment to the BLA, Standard Operating Procedures for the four test methods
(Sterility, ----b(4)------ and Potency assays for Fibrinogen and Thrombin).
3. Please submit, in an amendment to the BLA, the rationale and justifications for the proposed proper names for EVARREST.
4. Please revise the attached Lot Release Protocol.
Please respond to this information request as an amendment to this file, referencing the date of t
Fibrin Pad BLA
125392 BRP Draf...
is request by July 30, 2012. If you anticipate you will not be able to respond by July 30th, please contact me immediately so a new response date can be identified.
The review of this submission is ongoing and issues may be added, expanded upon, or modified as we continue to review this submission.
The resubmission action due date for this file is September 29, 2012. If you have any questions, please contact me at (301) 827-9427. Sincerely,
Tracy Tilghman, MPH
Lieutenant, United States Public Health Service
Regulatory Project Manager
U.S. Food & Drug Administration
1401 Rockville Pike
RM 556N, HFM-380
Rockville, MD 20852
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