Product Approval Information
TELECON
| 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) |
BL 125204/0 |
Anti-K (Monoclonal) |
BL 125205/0 |
Anti-c (Monoclonal) |
BL 125206/0 |
Anti-C (Monoclonal) |
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:
- Please provide the following items for all biological products (STNs) that are pending for approval.
- Definition for the date of manufacture
- Dating period
- 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