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From: Smith, Michael (CBER)
Sent: Wednesday, August 18, 2021 4:01 PM
To: Rohlfing, Paul <[email protected]>
Cc: Gottschalk, Laura <[email protected]>; Naik, Ramachandra
<[email protected]>; Aghajani Memar, Neda <[email protected]>;
Harkins Tull, Elisa <[email protected]>
Subject: RE: [EXTERNAL] FW: STN 125742.0: IR RE sh elf life and date of manufacture
Paul,
Regarding your question, we expect that it will be sufficient to provide batched updates within a reasonable period of time after having a group of batches with
data to report at 9, 12, 18, and 24 months. You may submit this information as
product correspondence or in your annual report, as appropriate for the timing of the collected data. Please comment on when you anticipate sending a post -
marketing supplement to extend the expiry dating period and provide a brief description of the information you expect to submit to support that expiry dating
period extension.
Regards ,
Mike
From: Rohlfing, Paul < [email protected] >
Sent: Wednesday, August 18, 2021 8:36 AM
To: Smith, Michael (CBER) < [email protected] >
Cc: Gottschalk, Laura < [email protected] >; Naik, Ramachandra
<[email protected] >; Aghajani Memar, Neda < [email protected] >;
Harkins Tull, Elisa < Elisa.HarkinsTull@p fizer.com >
Subject: [EXTERNAL] FW: STN 125742.0: IR RE shelf life and date of manufacture
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Mike,
Mike,
Can you clarify what CBER has in mind by “real time”? Taken literally that might be interpreted as
reporting each time point, of each lot in the stability program (more than lots at this point. We would not be prepared to make updates that frequently. Updates within a reasonable period of time after
having a group of batches with data to report at 12, 18, and 24 months would be more reasonable. Would that be consistent with what CBER is expecting?
(b) (4)
FDA-CBER-2021-5683-1150276
Regards,
Paul
From: Smith, Michael (CBER) < [email protected]
>
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: [EXTERNAL] STN 1 25742.0: IR RE shelf life and date of manufacture
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.
Regar ds,
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
FDA-CBER-2021-5683-1150277
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150278