Document text
From: Gottschalk, Laura
Sent: Thursday, August 5, 2021 11:45 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 Proper Name
Dear Ms. Harkins,
Please note that the PROPER NAME to be used for your product in this BLA is “COVID -19
Vaccine, mRNA”.
Please let us know if you have any questions. Best regards,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Bio logics 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, dissemination, 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-2021-5683-1150211