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From: Wang, Hsiaoling <[email protected]>
Sent: Monday, August 30, 2021 3:10 PM
To: Smith, Michael (CBER) <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Sutkowski, Elizabeth M. <[email protected]>;
Eichelberger, Maryna <[email protected]>; Pan, Tao <[email protected]>; Francis,
Kori <[email protected]>
Subject: RE: STN 125742.0.41: Response to DBSQC IR RE testing related limits for established
and polydispersity index
Hi Mike:
I reviewed the amendment 41 (received on 8/11/2021) and it is acce ptable. The data (established limits
for the control) was used in DLS test memo, which I uploaded on 8/20/2021.
Thank you,
Charlene
From: Smith, Michael (CBER) < [email protected] >
Sent: Monday, August 30, 2021 2:53 PM
To: Wang, Hsiaoling < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Sutkowski, Elizabeth M. < [email protected] >;
Eichelberger, Maryna <[email protected] >; Pan, Tao < [email protected] >; Francis,
Kori < [email protected] >
Subject: STN 125742.0.41: Response to DBSQC IR RE testing related limits for established
and polydispersity index
Charlene,
Pfizer submitted amendment 41 on August 11th in response to your August 10th
IR, but I don’t see that you mention that in your review (attached). Can you
please respond to this e -mail and indicate that you reviewed amendment 41
submitted on August 11, 2021, and found their response to be acceptable?
Thanks,
Mike
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FDA-CBER-2021-5683-1150381