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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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8/5/2008 Telecon - Seraclone Anti-s (Monoclonal)

Date/Time: August 5, 2008 / 07:35 AM
CBER Representative: Najma Khan
Biotest’ Representative: Ute Greiner
Through: John A. Eltermann, Jr., Director, DMPQ, HFM-670
Subject: Discuss additional information required for submission.
To: Files of STNs listed below
Submission Tracking Numbers Product Proper Names
BL 125202/0 Anti-E (Monoclonal)
(Formulated for Automated Testing)
BL 125203/0 Anti-e (Monoclonal)
(Formulated for Automated Testing)
BL 125204/0 Anti-K (Monoclonal)
(Formulated for Automated Testing)
BL 125205/0 Anti-c (Monoclonal)
(Formulated for Automated Testing)
BL 125206/0 Anti-C (Monoclonal)
(Formulated for Automated Testing)
BL 125207/0 Reagent Red Blood Cells
BL 125208 Reagent Red Blood Cells (Formulated for Automated Testing)
BL 125212/0 Anti-Fy a (Monoclonal)
BL 125213/0 Blood Grouping Reagent, Anti-P 1 (Murine Monoclonal)
BL 125214/0 Anti-s (Monoclonal)
BL 125215/0 Anti-Human Globulin
BL 125216/0 Blood Grouping Reagent, Anti-S (Monoclonal)
BL 125217/0 Blood Grouping Reagent, Anti-Jkb (Monoclonal)
BL 125218/0 Anti-D (Monoclonal)(IgG Blend)(Formulated for Automated Testing)
BL 125219/0 Blood Grouping Reagent, Anti-A (Murine Monoclonal)
BL 125220/0 Blood Grouping Reagent, Anti-B (Murine Monoclonal)
BL 125221/0 Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)
BL 125222/0 Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)
BL 125223/0 Blood Grouping Reagent, Anti-D (Monoclonal Blend)
BL 125224/0 Blood Grouping Reagent, Anti-M (Murine Monoclonal)
BL 125225/0 Blood Grouping Reagent, Anti-N (Murine Monoclonal)
BL 125226/0 Blood Grouping Reagent, Anti-C (Monoclonal)
BL 125227/0 Blood Grouping Reagent, Anti-c ((Monoclonal)
BL 125228/0 Blood Grouping Reagent, Anti-E ((Monoclonal)
BL 125229/0 Blood Grouping Reagent, Anti-e ((Monoclonal)
BL 125230/0 Blood Grouping Reagent, Anti-K (Monoclonal)
BL 125231/0 Blood Grouping Reagent, Anti-Jka ((Monoclonal)
BL 125232/0 Blood Grouping Reagent, Anti-k (Murine Monoclonal)
BL 125233/0 Blood Grouping Reagent, Anti-Le a (Murine Monoclonal)
BL 125242/0 Anti-Human Globulin (Rabbit/Murine Monoclonal)
BL 125097/10 Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)
BL 125098/8 Anti-Human Globulin (Formulated for Automated Testing)

Introduction : Biotest AG applied for Biological License Applications (BLAs) for Blood Grouping Reagents, Reagent Red Blood Cells and Anti-Human Globulin.

Discussion: The question from FDA is in bold and italicized text is the response from the sponsor. The following one issue was discussed:

  1. Please provide the following items for all biological products (STNs) that are pending for approval.
    1. Definition for the date of manufacture
    2. Dating period
    3. Product fill volume
      Biotest promised to fax the response within few hours.

Agreements/Decisions/Action:

  • Biotest will fax the response.

Prepared by Najma Khan on August 5, 2008

 

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