Document text
From: Smith, Michael (CBER)
Sent: Wednesday, June 29, 2022 10:35 AM
To:'Mineo, Gosia'
Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <Laura.G [email protected]>;
MaguireThon, Meghan <[email protected]>; 'D evlin, Carmel M' <[email protected]>; 'Harkins
Tull, Elisa' <[email protected]>; 'C orpuz, Katherine'
Subject: STN 125742/45: Request for resubmission of PI w/ 7/202 2 added for the date under "recent major changes"
and "revision date"
Gosia,
We acknowledge receipt of the revised Package Inse rt (PI) that was submitted to STN 125742/45 on
May 13, 2022. Please resubmit it to the BLA on Friday, July 1, 2022, and replace “M/YYYY” with
“7/2022” for the date under "recent major changes" and "revision date" on page one of the highlights
page (three instances). Please do not ma ke any other changes to the PI.
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 Applications
Tel: [email protected]
Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.07.05 10:55:58 -04'00'
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FDA-CBER-2022-5812-0500497
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FDA-CBER-2022-5812-0500498