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Vaccines, Blood & Biologics

7/31/2007 Fax - RECOTHROM


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

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


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: -----ºC"


  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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 05/23/2016
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