Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,

I have a question about submission of pre-IND meeting requests and briefing packages to CBER.....  Must these be in eCTD formation, electronically published and submitted via the ESG?  I know that, at the initial IND stage and thereafter, this is the requirement, but I am unclear with regards to the pre-IND activities.

Thanks so much for your help!

This message was posted by a user wishing to remain anonymous

Hey,
Yes, right now (during the Covid pandemic), you should submit pre-IND packages in eCTD format via the ESG. Before Covid, you could also submit via mail (CD), so the FDA may revert back to allowing this option in the future. Below is text from our PM at FDA.
Good luck!

FDA Submissions during COVID Pandemic

Due to COVID-19 closure, the Document Control Center (DCC) will not process any submissions received by mail or courier including submissions provided on paper and electronic media (e.g., CDs, USB drives) after Wednesday, April 29, 2020, until further notice. Submission previously submitted by mail can still be sent through the Electronic Submission Gateway (ESG) or in some cases by e-mail. CBER strongly encourages sending submissions (under 10GB) through FDA's preferred secure method of transmission, the ESG. Commercial applicants and sponsors should continue to submit in standard eCTD format using the ESG as described in guidance for industry, Providing Regulatory Submission in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

Applicants and sponsors exempt from eCTD submission requirements (e.g., research) may submit a PDF version to the DCC via email at CBERDCC_eMailSub@fda.hhs.gov. However, we draw  your attention to the option of submission via the ESG using the alternate (non- eCTD) format,  as described in draft guidance  Providing Regulatory Submissions in Alternate Electronic  Format.

 Applicants and sponsors of biological product submissions that are exempt from eCTD requirements, as well as applicants and sponsors of device submissions who are experiencing  difficulty sending submissions using the preferred secured methods, or do not have an ESG account may send submissions (under 150MB) via email at  CBERDCC_eMailSub@fda.hhs.gov. We will accept these submissions through this email option only during the COVID-19 public health emergency.

 For additional information see COVID-19 CBER Regulated Biologics

Original Message:
Sent: 09-Apr-2021 10:17
From: Anonymous Member
Subject: Pre-IND Meeting Request/Package to CBER

This message was posted by a user wishing to remain anonymous

Hello everyone,

I have a question about submission of pre-IND meeting requests and briefing packages to CBER.....  Must these be in eCTD formation, electronically published and submitted via the ESG?  I know that, at the initial IND stage and thereafter, this is the requirement, but I am unclear with regards to the pre-IND activities.

Thanks so much for your help!

This message was posted by a user wishing to remain anonymous

Thank you so much!  This is very helpful.
Original Message:
Sent: 12-Apr-2021 11:55
From: Anonymous Member
Subject: Pre-IND Meeting Request/Package to CBER

This message was posted by a user wishing to remain anonymous

Hey,
Yes, right now (during the Covid pandemic), you should submit pre-IND packages in eCTD format via the ESG. Before Covid, you could also submit via mail (CD), so the FDA may revert back to allowing this option in the future. Below is text from our PM at FDA.
Good luck!

FDA Submissions during COVID Pandemic

Due to COVID-19 closure, the Document Control Center (DCC) will not process any submissions received by mail or courier including submissions provided on paper and electronic media (e.g., CDs, USB drives) after Wednesday, April 29, 2020, until further notice. Submission previously submitted by mail can still be sent through the Electronic Submission Gateway (ESG) or in some cases by e-mail. CBER strongly encourages sending submissions (under 10GB) through FDA's preferred secure method of transmission, the ESG. Commercial applicants and sponsors should continue to submit in standard eCTD format using the ESG as described in guidance for industry, Providing Regulatory Submission in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

Applicants and sponsors exempt from eCTD submission requirements (e.g., research) may submit a PDF version to the DCC via email at CBERDCC_eMailSub@fda.hhs.gov. However, we draw  your attention to the option of submission via the ESG using the alternate (non- eCTD) format,  as described in draft guidance  Providing Regulatory Submissions in Alternate Electronic  Format.

 Applicants and sponsors of biological product submissions that are exempt from eCTD requirements, as well as applicants and sponsors of device submissions who are experiencing  difficulty sending submissions using the preferred secured methods, or do not have an ESG account may send submissions (under 150MB) via email at  CBERDCC_eMailSub@fda.hhs.gov. We will accept these submissions through this email option only during the COVID-19 public health emergency.

 For additional information see COVID-19 CBER Regulated Biologics

Original Message:
Sent: 09-Apr-2021 10:17
From: Anonymous Member
Subject: Pre-IND Meeting Request/Package to CBER

This message was posted by a user wishing to remain anonymous

Hello everyone,

I have a question about submission of pre-IND meeting requests and briefing packages to CBER.....  Must these be in eCTD formation, electronically published and submitted via the ESG?  I know that, at the initial IND stage and thereafter, this is the requirement, but I am unclear with regards to the pre-IND activities.

Thanks so much for your help!