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FDA-CBER-2022-5812-0236383
Confirming receipt. We will discuss with the review team regarding your proposal to provide the 508-
compliant tables.
As suggested, we will continue to include Elisa and Carmel in any correspondence in your absence.
Regards,
Ram
From: Patel, Amit < [email protected] > Sent: Thursday, November 11, 2021 4:31 PM
To: Naik, Ramachandra < [email protected] >
Cc: Smith, Michael (CBER) < [email protected] >; Gottschalk, Laura
<[email protected] >; Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M
<[email protected] >
Subject: [EXTERNAL] RE: Re: COVID BLA 125742 - Question relating to the 508 tables - sBLA 12-15 years
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
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Hi Ram,
Apologies in my haste to send the email I omitted the relevant clarifying background information. In the
attached CBER correspondence CBER responses to the Request for Comments and Advice regarding the
supplemental BLA for adolescents 12 through 15 years of age dated 24 September 2021 (IND 19736
amendment 434), CBER has made specific reference to also be providing shell tables specific to this sBLA
Pfizer/BioNTech is alternatively proposing to deliver the 508 table outputs (covering only 12-15 years
subjects) based on the previous submitted 508 shell tables for the upcoming sBLA 12-15 years planned
for 17 December 2021.
Please let me know if you have any questions or concerns,
Thanks
Amit
From: Patel, Amit
Sent: Thursday, November 11, 2021 2:59 PM
To: Naik, Ramachandra < [email protected] > Cc: Smith, Michael (CBER) < [email protected] >; Gottschalk, Laura
<[email protected] >; Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M
<[email protected] >
Subject: Re: COVID BLA 125742 - Question relating to the 508 tables - sBLA 12-15 years
Hi Ram,
FDA-CBER-2022-5812-0236384
Pfizer/BioNTech proposes to deliver the 508 table outputs (covering only 12-15 years subjects) based on
the previous submitted 508 shell tables for the upcoming supplemental BLA 12-15 years submission
planned for 17 December 2021.
Please let me know if you have any questions or concerns or would like to discuss further in a call. Also I
wanted to take this opportunity to notify you that I
inclusive. Please continue to include Elisa and Carmel in any correspondence
Thanks
Amit
Amit Patel
Director
Global Product Development
Global Regulatory Affairs -Vaccines
M: (214) 918 5262
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0236385