Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Is it a new IND undergoing 30-day review? If so, is the study started outside the US and this safety incident from the site outside US? Your question is bit troubling without the clarification.
Original Message:
Sent: 27-Oct-2020 13:49
From: Vasundhara Pathak
Subject: Dear Investigator Letter for IND Application under review

Dear All,

Should we submit the DIL to FDA for a study for which IND application is under review by FDA if there is a safety finding for a drug included in this study? Or Should we wait until we have final FDA approval/rejection on IND application?

Do we need to submit DIL to IRB/IEC in this case?

When are the protocol and ICF updates required in this case?

Thanks,

Vasundhara

Thanks for your reply. The IND under review is for a new study. The safety finding is from another study (not same study at non-US site) for a molecule which is also included in the study for which IND in under 30 day review period.

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Vasundhara Pathak
Warren NJ
United States
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Original Message:
Sent: 27-Oct-2020 19:06
From: Anonymous Member
Subject: Dear Investigator Letter for IND Application under review

This message was posted by a user wishing to remain anonymous

Is it a new IND undergoing 30-day review? If so, is the study started outside the US and this safety incident from the site outside US? Your question is bit troubling without the clarification.
Original Message:
Sent: 27-Oct-2020 13:49
From: Vasundhara Pathak
Subject: Dear Investigator Letter for IND Application under review

Dear All,

Should we submit the DIL to FDA for a study for which IND application is under review by FDA if there is a safety finding for a drug included in this study? Or Should we wait until we have final FDA approval/rejection on IND application?

Do we need to submit DIL to IRB/IEC in this case?

When are the protocol and ICF updates required in this case?

Thanks,

Vasundhara

Agree with the Anonymous: 1. Since the molecule is the same for both studies, and 2. I am assuming that this new safety finding from another study impacts the IB that was submitted with the new IND under current 30-day review at the FDA.

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GRSAOnline
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Original Message:
Sent: 29-Oct-2020 00:49
From: Vasundhara Pathak
Subject: Dear Investigator Letter for IND Application under review

Thanks for your reply. The IND under review is for a new study. The safety finding is from another study (not same study at non-US site) for a molecule which is also included in the study for which IND in under 30 day review period.

------------------------------
Vasundhara Pathak
Warren NJ
United States

Original Message:
Sent: 27-Oct-2020 19:06
From: Anonymous Member
Subject: Dear Investigator Letter for IND Application under review

This message was posted by a user wishing to remain anonymous

Is it a new IND undergoing 30-day review? If so, is the study started outside the US and this safety incident from the site outside US? Your question is bit troubling without the clarification.
Original Message:
Sent: 27-Oct-2020 13:49
From: Vasundhara Pathak
Subject: Dear Investigator Letter for IND Application under review

Dear All,

Should we submit the DIL to FDA for a study for which IND application is under review by FDA if there is a safety finding for a drug included in this study? Or Should we wait until we have final FDA approval/rejection on IND application?

Do we need to submit DIL to IRB/IEC in this case?

When are the protocol and ICF updates required in this case?

Thanks,

Vasundhara

This message was posted by a user wishing to remain anonymous

Is your IND new and under 30 day review at the FDA ? The safety finding related to the drug (under review at the FDA) coming in from outside the US from a non-US site where the study is already approved? If so, you need to submit this to the FDA right away before the 30-day IND review is complete! Else, you will be accused of withholding safety information.
Original Message:
Sent: 27-Oct-2020 13:49
From: Vasundhara Pathak
Subject: Dear Investigator Letter for IND Application under review

Dear All,

Should we submit the DIL to FDA for a study for which IND application is under review by FDA if there is a safety finding for a drug included in this study? Or Should we wait until we have final FDA approval/rejection on IND application?

Do we need to submit DIL to IRB/IEC in this case?

When are the protocol and ICF updates required in this case?

Thanks,

Vasundhara