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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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7/31/2007 Fax - RECOTHROM

FACSIMILE TRANSMISSION RECORD

Division of Blood Applications
1401 Rockville Pike, Suite 400N, HFM-380
Rockville, Maryland 20852-1448

FAX (301) 827-3534
TEL (301) 827-6173

31-Jul-07

FAX No. 206-428-4030
To: Mark Gauthier, Regulatory Affairs
This Fax is regarding STN 125248/0 that was submitted to the agency on 18-Dec-06, designated as a New BLA for manufacture of Thrombin (Recombinant).

The following comments are regarding the Lot Release Protocol.

Reviewers' Information Request

  1. Page 1 issues

     

    1. First line should read - cc: 125248-0/1758-FC
    2. Under Reason for Submission, For Licensing Action - remove "/License # 1758. It is not needed.
    3. Under the Fill Information before the Recommended Reconstitution Volume, please add the "Storage Conditions: -----ÂșC"

     

  2. Page 2 Issues

     

    1. First line should read - cc: 125248-0/1758-FC
    2. Each sterility test should be displayed separately.

Information provided by: J. Quander III     Date: 31 Jun-07

Approved by R. Drews   Date 31-Jun-07   Transmitted by M. Shields   Date: 31Jun-07

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448