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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-Fya (Monoclonal)

Telephone Conversation

Public Health Service Memorandum

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 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-Fya (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

Return to Blood Grouping Reagent Anti-Fya (Monoclonal) - Seraclone - Approval History, Letters, Reviews, and Related Documents page