Document text
From: Gottschalk, Laura <[email protected]>
Sent: Thursday, August 19, 2021 12:54 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik,
Ramachandra <[email protected]>
Subject: STN 125742.0: 6th set of PI labeling comments - please respond by COB today
Dear Elisa,
Attached is the 6
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 COB today, August 19, 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 Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not
the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, disseminatio n, copying, or other action based on the content of this communication is not authorized. If you
have received this document in error, please immediately notify the sender by e- mail or phone.
FDA-CBER-2021-5683-1024834