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From: Smith, Michael (CBER)
Sent: Friday, August 13, 2021 6:22 PM
To: Aghajani Memar, Neda <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>
Subject: STN 125742.0: 3rd set of PI labeling comments
Neda,
We have the attached 3rd set of comments on the Package Insert (PI). Please e -
mail us the further revised PI (both Word tracked- changes and Word annotated)
by noon Monday, August 16, 2021, and follow up with a submission to the BLA. Please note that w e will have additional comments for you on the PI next
week.
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]
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FDA-CBER-2021-5683-1024793
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FDA-CBER-2021-5683-1024794