Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

I don't know of a specific guidance regarding the submission dates on the forms or cover letter. The Instructions for 1571 state that the date in Field 23 is the date the form was signed and may be different from the date in Field 2. In the past when paper submissions were made, FDA referred to the "submission dated xxxxx and received on xxxxx." My recent experience is only to "received on xxxxx" and refers to the date that it was successfully accepted through the ESG. All that said, I think standard practice (at least mine) is to sign the cover letter and 1571 on the dates they are being transmitted.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

Hi Glen,

Thanks for your response. There will be situations where submission is planned on a specific day but gets pushed by a day or two due to some constraints. In these situations, sponsors usually change the submission date in Form 1571 and cover letter and resign the documents. My intention is whether this can be avoided if FDA accepts the submission with submission dates in Form 1571 and cover letter different from the date that is transmitted through the ESG gateway.

Cheers.


Original Message:
Sent: 28-May-2020 08:17
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

I don't know of a specific guidance regarding the submission dates on the forms or cover letter. The Instructions for 1571 state that the date in Field 23 is the date the form was signed and may be different from the date in Field 2. In the past when paper submissions were made, FDA referred to the "submission dated xxxxx and received on xxxxx." My recent experience is only to "received on xxxxx" and refers to the date that it was successfully accepted through the ESG. All that said, I think standard practice (at least mine) is to sign the cover letter and 1571 on the dates they are being transmitted.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

Original Message:
Sent: 5/28/2020 11:56:00 AM
From: GOUTHAM REDDY KANCHARLA
Subject: RE: Submission Date in FDA Forms and Cover Letter

Hi Glen,

Thanks for your response. There will be situations where submission is planned on a specific day but gets pushed by a day or two due to some constraints. In these situations, sponsors usually change the submission date in Form 1571 and cover letter and resign the documents. My intention is whether this can be avoided if FDA accepts the submission with submission dates in Form 1571 and cover letter different from the date that is transmitted through the ESG gateway.

Cheers.


Original Message:
Sent: 28-May-2020 08:17
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

I don't know of a specific guidance regarding the submission dates on the forms or cover letter. The Instructions for 1571 state that the date in Field 23 is the date the form was signed and may be different from the date in Field 2. In the past when paper submissions were made, FDA referred to the "submission dated xxxxx and received on xxxxx." My recent experience is only to "received on xxxxx" and refers to the date that it was successfully accepted through the ESG. All that said, I think standard practice (at least mine) is to sign the cover letter and 1571 on the dates they are being transmitted.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

Thanks Glen.


Original Message:
Sent: 28-May-2020 12:00
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

The dates on the documents are not part of the eCTD validation criteria. I have never had a submission rejected because the document date was different from the submission date.

 

Glen D. Park, PharmD, MSJ 

Executive Director, Regulatory Affairs & Quality Assurance

 

| Work: +1.201.884.5495 | Mobile: +1.212.945.8512 

| glen.park@scynexis.com | www.scynexis.com |

 

Original Message:
Sent: 5/28/2020 11:56:00 AM
From: GOUTHAM REDDY KANCHARLA
Subject: RE: Submission Date in FDA Forms and Cover Letter

Hi Glen,

Thanks for your response. There will be situations where submission is planned on a specific day but gets pushed by a day or two due to some constraints. In these situations, sponsors usually change the submission date in Form 1571 and cover letter and resign the documents. My intention is whether this can be avoided if FDA accepts the submission with submission dates in Form 1571 and cover letter different from the date that is transmitted through the ESG gateway.

Cheers.


Original Message:
Sent: 28-May-2020 08:17
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

I don't know of a specific guidance regarding the submission dates on the forms or cover letter. The Instructions for 1571 state that the date in Field 23 is the date the form was signed and may be different from the date in Field 2. In the past when paper submissions were made, FDA referred to the "submission dated xxxxx and received on xxxxx." My recent experience is only to "received on xxxxx" and refers to the date that it was successfully accepted through the ESG. All that said, I think standard practice (at least mine) is to sign the cover letter and 1571 on the dates they are being transmitted.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

I always date the form with the same date of my e-signature.  And because the submission then goes back to the client (or their e-submission publisher) for submission through the Gateway it never goes in the same day as the form date.  FDA has never had an issue with it.  And sometimes the FDA receipt takes a day or two anyway so there are lots of dates.  So when referencing the submission later I simply give some details like "submission dated xxx."

------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com
------------------------------

Original Message:
Sent: 28-May-2020 12:00
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

The dates on the documents are not part of the eCTD validation criteria. I have never had a submission rejected because the document date was different from the submission date.

 

Glen D. Park, PharmD, MSJ 

Executive Director, Regulatory Affairs & Quality Assurance

 

| Work: +1.201.884.5495 | Mobile: +1.212.945.8512 

| glen.park@scynexis.com | www.scynexis.com |

 

Original Message:
Sent: 5/28/2020 11:56:00 AM
From: GOUTHAM REDDY KANCHARLA
Subject: RE: Submission Date in FDA Forms and Cover Letter

Hi Glen,

Thanks for your response. There will be situations where submission is planned on a specific day but gets pushed by a day or two due to some constraints. In these situations, sponsors usually change the submission date in Form 1571 and cover letter and resign the documents. My intention is whether this can be avoided if FDA accepts the submission with submission dates in Form 1571 and cover letter different from the date that is transmitted through the ESG gateway.

Cheers.


Original Message:
Sent: 28-May-2020 08:17
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

I don't know of a specific guidance regarding the submission dates on the forms or cover letter. The Instructions for 1571 state that the date in Field 23 is the date the form was signed and may be different from the date in Field 2. In the past when paper submissions were made, FDA referred to the "submission dated xxxxx and received on xxxxx." My recent experience is only to "received on xxxxx" and refers to the date that it was successfully accepted through the ESG. All that said, I think standard practice (at least mine) is to sign the cover letter and 1571 on the dates they are being transmitted.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

This message was posted by a user wishing to remain anonymous

Thanks Smith for your response.

Cheers.
Original Message:
Sent: 29-May-2020 11:06
From: Christopher Smith
Subject: Submission Date in FDA Forms and Cover Letter

I always date the form with the same date of my e-signature.  And because the submission then goes back to the client (or their e-submission publisher) for submission through the Gateway it never goes in the same day as the form date.  FDA has never had an issue with it.  And sometimes the FDA receipt takes a day or two anyway so there are lots of dates.  So when referencing the submission later I simply give some details like "submission dated xxx."

------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com

Original Message:
Sent: 28-May-2020 12:00
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

The dates on the documents are not part of the eCTD validation criteria. I have never had a submission rejected because the document date was different from the submission date.

 

Glen D. Park, PharmD, MSJ 

Executive Director, Regulatory Affairs & Quality Assurance

 

| Work: +1.201.884.5495 | Mobile: +1.212.945.8512 

| glen.park@scynexis.com | www.scynexis.com |

 

Original Message:
Sent: 5/28/2020 11:56:00 AM
From: GOUTHAM REDDY KANCHARLA
Subject: RE: Submission Date in FDA Forms and Cover Letter

Hi Glen,

Thanks for your response. There will be situations where submission is planned on a specific day but gets pushed by a day or two due to some constraints. In these situations, sponsors usually change the submission date in Form 1571 and cover letter and resign the documents. My intention is whether this can be avoided if FDA accepts the submission with submission dates in Form 1571 and cover letter different from the date that is transmitted through the ESG gateway.

Cheers.


Original Message:
Sent: 28-May-2020 08:17
From: Glen Park
Subject: Submission Date in FDA Forms and Cover Letter

I don't know of a specific guidance regarding the submission dates on the forms or cover letter. The Instructions for 1571 state that the date in Field 23 is the date the form was signed and may be different from the date in Field 2. In the past when paper submissions were made, FDA referred to the "submission dated xxxxx and received on xxxxx." My recent experience is only to "received on xxxxx" and refers to the date that it was successfully accepted through the ESG. All that said, I think standard practice (at least mine) is to sign the cover letter and 1571 on the dates they are being transmitted.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

This message was posted by a user wishing to remain anonymous

I think it is better to have it as the day of submission so if you are every looking back at the submission, you know for sure when it was submitted. I usually look at the cover letter.

I will say that I have at times signed the 1571 electronically 1 business day (so Friday before a Monday submission) and that was acceptable, but cover letter was still dated as date of the submission.
Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

Agree with Anonymous. We use date of submission on both cover letter and box 2. But sometimes sign 1571 in advance (box 23).

------------------------------
Tom
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 28-May-2020 15:48
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

I think it is better to have it as the day of submission so if you are every looking back at the submission, you know for sure when it was submitted. I usually look at the cover letter.

I will say that I have at times signed the 1571 electronically 1 business day (so Friday before a Monday submission) and that was acceptable, but cover letter was still dated as date of the submission.
Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.

Hi,

There isn't current guidance that states that your FDA form and cover letter date must match the date your submission goes through the ESG. In my experience there have been several cases where either I/ or the client did a last minute change or there have been general publishing team turnaround time variances that has caused the FDA form/Cover letter date to not match the actual ESG date. I've never had a issue or rejection due to the date variation from the FDA.

------------------------------
Octavia Green
Orlando FL
United States
------------------------------

Original Message:
Sent: 27-May-2020 15:52
From: Anonymous Member
Subject: Submission Date in FDA Forms and Cover Letter

This message was posted by a user wishing to remain anonymous

Hi all,

Can you please share your thoughts or any available FDA guidance regarding the submission date in Form 1571/356h and cover letter. Does the submission date in Form 1571/356h and cover letter need to match with the date submission is actually dispatched through the ESG gateway. Does a submission fail technical validation if there is mismatch between dates in Form 1571/356h versus the date submission is dispatched through the ESG gateway.

I appreciate your response in advance.

Cheers.