Document text
From: Gottschalk, Laura <[email protected]>
Sent: Saturday, August 21, 2021 10:37 AM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>
Subject: STN 125742.0: 8th set of PI labeling comments - please respond by 3:00pm today
Dear Elisa,
Attached is the 8
th set of comments from the review team on the Package Insert (PI). Please email us the
further revised PI (both Word tracked- changes and Word annotated) by 3:00pm today, August 21, 2021,
and follow up with a submission to the BLA.
Please acknowledge receipt and let me know if you have any questions.
Best,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vacci nes Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
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FDA-CBER-2021-5683-1024869