Regulatory Open Forum

Hi, 

I am preparing a response for the FDA request and I need to attach few CAPAs and, Investigations and reports with my submission.
Where I would place these documents within the eCTD (which section)? 

Thank you

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Valeria Shkuratova
Canada
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Hi Valeria, 

In my experience those documents would be included in Section 3.2.R Regional Section.  Documents included in this section provide supporing information but are not maintained with the eCTD lifecycle.  

Good luck with the FDA request.

Best regards,
Carolyn

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Carolyn Dougherty
Kalamazoo MI
United States
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Original Message:
Sent: 31-Jan-2023 16:45
From: Valeria Shkuratova
Subject: eCTD structure

Hi,

I am preparing a response for the FDA request and I need to attach few CAPAs and, Investigations and reports with my submission.
Where I would place these documents within the eCTD (which section)?

Thank you

------------------------------
Valeria Shkuratova
Canada
------------------------------

Hi Valeria,

Since submission of CAPAs is not defined in the eCTD structure, I probably would put the documents in Module 1.11 Information not covered under modules 2 to 5. If the CAPA is for manufacturing, then it would go in 1.11.1. If for other quality assurance requests, it could go in another appropriate section.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 31-Jan-2023 16:45
From: Valeria Shkuratova
Subject: eCTD structure

Hi,

I am preparing a response for the FDA request and I need to attach few CAPAs and, Investigations and reports with my submission.
Where I would place these documents within the eCTD (which section)?

Thank you

------------------------------
Valeria Shkuratova
Canada
------------------------------

Hi Valeria,

I agree with Glen, I would put it in 1.11.  I would also explain in the cover letter that the submission is in response to the Agency's request and include a copy of the request, if the request was in writing, or a summary of a voice conversation for context when the reviewer sees the submission.  You can link to the CAPAs, etc. in the cover letter.

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Ken Rose
Painesville OH
United States
------------------------------

Original Message:
Sent: 31-Jan-2023 16:45
From: Valeria Shkuratova
Subject: eCTD structure

Hi,

I am preparing a response for the FDA request and I need to attach few CAPAs and, Investigations and reports with my submission.
Where I would place these documents within the eCTD (which section)?

Thank you

------------------------------
Valeria Shkuratova
Canada
------------------------------