125742 45 02 07 2022 Memo Filing Checklist RPM A

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

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From:Zhang, Jianmin (Jack) <[email protected]> 
Sent:Wednesday, January 5, 2022 2:06 PM
To:Gottschalk, Laura <[email protected]>; Naik, Ramachandra 
<[email protected]>; Smith, Michael (CBER) <[email protected]>
Cc:Hussong, Virginia <[email protected]>; Lin, Lisa <[email protected]>; LopezMitnik, 
Gabriela <[email protected]>
Subject:The validation results for BLA125742\45 supplement attached
Importance: High
Dear Laura, Ram and Michael,
Please receive the validation results for BLA125742\45 supplement attached. These results will be used 
for discussion during tomorrow afternoon meeting that you have setup.
If you have any questions, please let us know.
Thanks,
Jack
Jack Zhang, M.D., Ph.D.
Biologist
Data Standards Staff
CBER
Office of the Center Director
Associate Director of Review Management,
U.S. Food and Drug Administration
Building 71/Room 1106
Tel:240-402-8187
[email protected]
FDA-CBER-2022-5812-0500338