Document text
From: Gottschalk, Laura
Sent: Saturday, August 21, 2021 11:11 AM
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 - Final Draft Labels: Carton and Containers
Dear Ms. Harkins,
We have reviewed your draft Carton and Container labels submitted in Amendment 63 to your BLA, dated August 19, 2021 (STN 125742/0.63; Seq 0064) and found them to be acceptable. CBER considers the Carton and Container labels included in Amendment 63 as the Final Draft Labels for approval.
Best regards,
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]
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FDA-CBER-2021-5683-1150342