Information Request Email, July 16, 2012 - EVARREST

Tilghman, Tracy 

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

 

Importance:                       High

 

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

CBER/OBRR/DBA/RPMB

1401 Rockville Pike

RM 556N, HFM-380

Rockville, MD  20852

Phone: 301-827-9427

Email: tracy.tilghman@fda.hhs.gov

 

 

 

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