Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)? 

Any input or guidance is appreciated.

Thank you.

I recommend that you contact the Project Manager of the Division to whom you intend to submit the request by telephone. FDA is very responsive to COVID-19 development requests. While you can send the meeting request by email, FDA does not consider it a formal submission, but I wouldn't let that stop you at this point. Get the PMs advice. They are flexible.

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

Original Message:
Sent: 19-May-2020 10:38
From: Anonymous Member
Subject: Pre-IND meeting request via secure email - COVID19

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)?

Any input or guidance is appreciated.

Thank you.

This message was posted by a user wishing to remain anonymous

Thank you so much!
Original Message:
Sent: 20-May-2020 09:46
From: Glen Park
Subject: Pre-IND meeting request via secure email - COVID19

I recommend that you contact the Project Manager of the Division to whom you intend to submit the request by telephone. FDA is very responsive to COVID-19 development requests. While you can send the meeting request by email, FDA does not consider it a formal submission, but I wouldn't let that stop you at this point. Get the PMs advice. They are flexible.

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

Original Message:
Sent: 19-May-2020 10:38
From: Anonymous Member
Subject: Pre-IND meeting request via secure email - COVID19

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)?

Any input or guidance is appreciated.

Thank you.

FDA is allowing the use of their NextGen Portal for Pre-IND submissions/communications. Go to the following website and read down to the bottom of the page. You will see that Option 2 is a route you can use without going through the Gateway.

https://www.fda.gov/drugs/coronavirus-covid-19-drugs/drug-development-inquiries-drugs-address-covid-19-public-health-emergency

Ric


------------------------------
Richard Newman PhD
Principal
Deerfield IL
United States
------------------------------

Original Message:
Sent: 19-May-2020 10:38
From: Anonymous Member
Subject: Pre-IND meeting request via secure email - COVID19

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)?

Any input or guidance is appreciated.

Thank you.

This message was posted by a user wishing to remain anonymous

Thank you very much, Richard. This is really helpful.
Original Message:
Sent: 20-May-2020 10:37
From: Richard Newman
Subject: Pre-IND meeting request via secure email - COVID19

FDA is allowing the use of their NextGen Portal for Pre-IND submissions/communications. Go to the following website and read down to the bottom of the page. You will see that Option 2 is a route you can use without going through the Gateway.

https://www.fda.gov/drugs/coronavirus-covid-19-drugs/drug-development-inquiries-drugs-address-covid-19-public-health-emergency

Ric


------------------------------
Richard Newman PhD
Principal
Deerfield IL
United States

Original Message:
Sent: 19-May-2020 10:38
From: Anonymous Member
Subject: Pre-IND meeting request via secure email - COVID19

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)?

Any input or guidance is appreciated.

Thank you.

If the product falls under CDER, you can submit the pre-IND meeting request as a PDF file via the FDA NextGen portal as an FDA Alternate Submission. 
https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=-1283440619_1589985366196&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp

Good luck!

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

Original Message:
Sent: 19-May-2020 10:38
From: Anonymous Member
Subject: Pre-IND meeting request via secure email - COVID19

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)?

Any input or guidance is appreciated.

Thank you.

This message was posted by a user wishing to remain anonymous

Thank you for sharing, Bridgette.
Original Message:
Sent: 20-May-2020 10:40
From: Bridgette Kunst
Subject: Pre-IND meeting request via secure email - COVID19

If the product falls under CDER, you can submit the pre-IND meeting request as a PDF file via the FDA NextGen portal as an FDA Alternate Submission.
https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=-1283440619_1589985366196&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp

Good luck!

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

Original Message:
Sent: 19-May-2020 10:38
From: Anonymous Member
Subject: Pre-IND meeting request via secure email - COVID19

This message was posted by a user wishing to remain anonymous

Hello,

We are working with an investigator who would like to submit a Pre-IND meeting request for a COVID19 related program at the earliest. Since contracting with an eCTD vendor is taking time, we are thinking if we could submit the briefing material via email.

Has anyone submitted a pre-ind meeting request via email? If yes, in order to establish a secure email, did you first obtain a digital certificate prior to sending a S/MIME request (SecureEmail@fda.hhs.gov)?

Any input or guidance is appreciated.

Thank you.