Document text
From: Smith, Michael (CBER)
Sent: Friday, August 13, 2021 12:32 PM
To: Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul
<[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>
Subject: STN 125742.0: Requests and instructions regarding test methods, the lot release process, and
the lot release protocol template
Importance: High
Neda and Paul,
The CBER DBSQC team has the attached requests and instructions regarding test
methods, the lot release process, and the lot release protocol template. Please
respond to this information request as soon as possible and preferably today.
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]
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
FDA-CBER-2021-5683-1150250
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
immediately by e- mail or phone.
FDA-CBER-2021-5683-1150251