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From: Smith, Michael (CBER)
Sent: Tuesday, July 5, 2022 10:51 AM
To:Mineo, Gosia
Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <Laura.G [email protected]>;
MaguireThon, Meghan <[email protected]>; Devlin, Carmel M <[email protected]>; Harkins
Tull, Elisa <[email protected]>; Co rpuz, Katherine
Subject: STN 125742/45: Final Draft Label of PI's
Gosia,
We have reviewed the Package Inserts that were submitted in Amendment 13 to STN 125742/45 on
Friday, July 1stand we found them to be acceptable. CBER co nsiders the clean versions of the PIs
included in Amendment 13 as the Final Draft Labels for approval.
Regards,Mike
- Please confirm receipt of this email 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 ApplicationsTel: 301-796-2640
michael.smith2 fda.hhs.gov
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g
Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.07.05 11:02:05 -04'00'
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FDA-CBER-2022-5812-0500502