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From: Smith, Michael (CBER)
Sent: Wednesday, August 18, 2021 5:18 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected]> Subject: STN 125742.0: 5th set of PI labeling comments - please respond by 10:00 AM Thursday
Elisa,
I attached the 5th set of comments from the review team on the Package Insert
(PI). Please e- mail us the further revised PI (both Word tracked- changes and
Word annotated) by 10:00 AM Thursday, August 19, 2021, and follow up with a submission to the BLA.
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-2021-5683-1024827
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FDA-CBER-2021-5683-1024828