Review Email, July 26, 2012 - EVARREST

Tilghman, Tracy

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From:                                Tilghman, Tracy

Sent:                                 Thursday, July 26, 2012 8:49 AM

To:                                    'Raina Dauria'

Cc:                                    Shields, Mark

Subject:                             Reference BL# 125392/0

 

Importance:                       High

 

 

 

Reference BL# 125392/0

 

Dear Ms. Dauria,

We are reviewing your November 4, 2010 submission for Fibrin Pad 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 to the BLA up-to-date stability data for the Process Validation Batches –b(4)----------------------------------------------- for all storage conditions. Please also submit, if available, stability data for any newly manufactured Batches of EVARREST.

 

2.   Regarding the container closure system, please describe your standard operating procedures for inspection of the final packaging and detection of –b(4)--- breaches in the package integrity.

 

Please respond to this information request as an amendment to this file, referencing the date of this request by August 13, 2012.  If you anticipate you will not be able to respond by August 13th , 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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