Regulatory Open Forum

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

This message was posted by a user wishing to remain anonymous

which therapeutic review division at the CDER?
Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

Division of Regulatory Operations for Urology, Obstetrics, and Gynecology

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

Original Message:
Sent: 10-Jul-2020 12:07
From: Anonymous Member
Subject: Type C Meeting Request Submission via ESG?

This message was posted by a user wishing to remain anonymous

which therapeutic review division at the CDER?
Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

Yes, I have had two Type B pre-IND submissions to CDER in the past two months. I both cases, they asked for an electronic submission in eCTD format. The meeting request goes in module 1.6.1 and the information package in 1.6.2. We requested an IND number and submitted an unsigned 1571 form with "Other--pre-IND" checked off for study phase and no serial number. They subsequently asked for some old pharm/tox and clinical study reports from a previous paper IND and requested those to be submitted in modules 4 and 5 of the pre-IND.
Phil

------------------------------
Philip Cross
Harbeson DE
United States
------------------------------

Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

Phil,

Thank you. I hadn't thought of submitting an unsigned 1571 and not using a sequence number.

Ken

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

Original Message:
Sent: 11-Jul-2020 10:45
From: Philip Cross
Subject: Type C Meeting Request Submission via ESG?

Yes, I have had two Type B pre-IND submissions to CDER in the past two months. I both cases, they asked for an electronic submission in eCTD format. The meeting request goes in module 1.6.1 and the information package in 1.6.2. We requested an IND number and submitted an unsigned 1571 form with "Other--pre-IND" checked off for study phase and no serial number. They subsequently asked for some old pharm/tox and clinical study reports from a previous paper IND and requested those to be submitted in modules 4 and 5 of the pre-IND.
Phil

------------------------------
Philip Cross
Harbeson DE
United States

Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

Hi Ken,
You can request the pIND number as well as submit pre-submission documents (i.e. pre-IND meeting request/briefing document) via the CDER NextGen Portal under "FDA Alternate Submission": 

https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=1077959211_1594499771930&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp

Good luck!
Bridgette

------------------------------
Bridgette Kunst RAC, MA
Managing Director
bkunst@bridgereg.com
------------------------------

Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

Hi Bridgette,

I did request the pIND via the CDER NextGen Portal.  I saw the eCTD Waived Submission option and wondered i it could apply to meeting requests but was not sure.  Thank you. I will use that option the next time.

Regards,
Ken

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

Original Message:
Sent: 11-Jul-2020 16:44
From: Bridgette Kunst
Subject: Type C Meeting Request Submission via ESG?

Hi Ken,
You can request the pIND number as well as submit pre-submission documents (i.e. pre-IND meeting request/briefing document) via the CDER NextGen Portal under "FDA Alternate Submission":

https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=1077959211_1594499771930&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp

Good luck!
Bridgette

------------------------------
Bridgette Kunst RAC, MA
Managing Director
bkunst@bridgereg.com

Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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

This message was posted by a user wishing to remain anonymous

Hi Ken,

To confirm, you need to request a pre-IND meeting if you don't have an IND in place. This would allow you to connect with the FDA regarding the studies needed for a NDA using a 505(b)(2) pathway. 

As for submitting the meeting request as eCTD via Gateway, it might be best for you to contact the division's project manager and ask if they would accept the submission by portal. I read on previous posts that FDA could accept PIND meeting requests through CDER NextGen Portal - though I cannot confirm this nor have I ever used this portal. You can no longer submit in paper.

My suggestion would be to submit your PIND meeting request and subsequent briefing package by eCTD. It would be easier to maintain and track in the future. 

Hope this helps but let me know if you have further questions. 

Original Message:
Sent: 10-Jul-2020 09:54
From: Ken Rose
Subject: Type C Meeting Request Submission via ESG?

Hello,

Has anyone experienced the FDA requiring Type C meeting requests to be submitted through the ESG in eCTD format?

This will be our client's first interaction with the FDA for this project.  We would like to have the FDA's opinion on a 505(b)(2) pathway before proceeding with development plans, as this will greatly affect the overall plan.

It seems unusual that we need to go through the entire eCTD process for the meeting request (not the packet, just the request). We need to request a PIND, fill out Form 1571, include Letters of Authorization, include a separate Cover Letter, and the meeting request.

This seems like an undue burden for the meeting request. But maybe that's the new norm.

I was just wondering if anyone else has experienced the same requirement.

Thanks,
Ken

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