Document text
From: Smith, Michael (CBER)
Sent: Tuesday, August 17, 2021 6:47 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: IR RE shelf life and date of manuf acture
Elisa,
The review team has two questions regarding shelf life and date of manufacture. Please respond as soon as possible and no later than 12:00 PM
Wednesday, August 18, 2021.
1. Please send information on what your final, intended drug product shelf life
will be and commit to submitting stability data in real time post licensure to
support this requested shelf life.
2. Please define your “date of manufacture” for the final, undiluted drug product.
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]
FDA-CBER-2021-5683-1150265
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, copyi ng, 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 immediately by e- mail or phone.
FDA-CBER-2021-5683-1150266