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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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8/5/2008 Telecon - Seraclone Blood Grouping Reagent Anti-S (Monoclonal)

Date/Time:August 5, 2008 / 07:35 AM
CBER Representative:Najma Khan
Biotest’ Representative:Ute Greiner
Subject:Discuss additional information required for submission.
To:Files of STNs listed below

 

Submission Tracking NumbersProduct 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 125207/0Reagent Red Blood Cells
BL 125208Reagent Red Blood Cells (Formulated for Automated Testing)
BL 125212/0Anti-Fy a (Monoclonal)
BL 125213/0Blood Grouping Reagent, Anti-P 1 (Murine Monoclonal)
BL 125214/0Anti-s (Monoclonal)
BL 125215/0Anti-Human Globulin
BL 125216/0Blood Grouping Reagent, Anti-S (Monoclonal)
BL 125217/0Blood Grouping Reagent, Anti-Jkb (Monoclonal)
BL 125218/0Anti-D (Monoclonal)(IgG Blend)(Formulated for Automated Testing)
BL 125219/0Blood Grouping Reagent, Anti-A (Murine Monoclonal)
BL 125220/0Blood Grouping Reagent, Anti-B (Murine Monoclonal)
BL 125221/0Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)
BL 125222/0Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)
BL 125223/0Blood Grouping Reagent, Anti-D (Monoclonal Blend)
BL 125224/0Blood Grouping Reagent, Anti-M (Murine Monoclonal)
BL 125225/0Blood Grouping Reagent, Anti-N (Murine Monoclonal)
BL 125226/0Blood Grouping Reagent, Anti-C (Monoclonal)
BL 125227/0Blood Grouping Reagent, Anti-c ((Monoclonal)
BL 125228/0Blood Grouping Reagent, Anti-E ((Monoclonal)
BL 125229/0Blood Grouping Reagent, Anti-e ((Monoclonal)
BL 125230/0Blood Grouping Reagent, Anti-K (Monoclonal)
BL 125231/0Blood Grouping Reagent, Anti-Jka ((Monoclonal)
BL 125232/0Blood Grouping Reagent, Anti-k (Murine Monoclonal)
BL 125233/0Blood Grouping Reagent, Anti-Le a (Murine Monoclonal)
BL 125242/0Anti-Human Globulin (Rabbit/Murine Monoclonal)
BL 125097/10Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)
BL 125098/8Anti-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

 

 

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