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From: Smith, Michael (CBER)
Sent: Wednesday, August 11, 2021 10:27 AM
To: Aghajani Memar, Neda <[email protected]>; Harkins Tull, Elisa
<[email protected]>; Devlin, Carmel M <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: Diluent IR
Neda,
The review team has the below question regarding the diluent that is to be provided in the BLA. They have requested a response as soon as possible and no
later than noon Friday, August 13, 2021.
1. In reference to the diluent that will be used with your COVID -19 vaccine (sterile
0.9% Sodium Chloride Injection, USP) “2 mL single dose” and “10 mL single
dose” vials:
a. Please update Section 3.2.P.3.1. MANUFACTURER(S) of your BLA to include the manufacturers of each vial si ze, including their address and
FEI numbers.
b. Please update FDA Form 356h to include the information related to your diluent manufacturers.
c. Please provide a summary of the shipping procedures for the “2 mL single dose” and “10 mL single dose” vials including the origin of distribution,
shipping responsible party, carton sizes, description of the shipper (box)
and shipping configuration, and the established shipping controls.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
FDA-CBER-2021-5683-1150238
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FDA-CBER-2021-5683-1150239