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From: Smith, Michael (CBER)
Sent: Thursday, August 5, 2021 3:37 PM
To: 'Harkins Tull, Elisa' <[email protected]>; 'Aghajani Memar, Neda'
<[email protected]>; 'Devlin, Carmel M' <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected] ov>
Subject: STN 125742.0: Second round of PI comments
Elisa,
Please find attached the second round of labeling comments on the Package Insert (PI) from the review team. The review team has requested a response by
COB Monday, August 9, 2021.
Regard s,
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-2021-5683-1024729