Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.  

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates? 

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

You should email the RPM and ask if the review team agrees with your request to submit the updated IB and revised protocol.

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
------------------------------

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

This message was posted by a user wishing to remain anonymous

Thank you for your helpful input, Juliane.

Appreciatively...
Original Message:
Sent: 17-May-2022 17:15
From: Juliane Carvalho
Subject: IB update timing

You should email the RPM and ask if the review team agrees with your request to submit the updated IB and revised protocol.

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

Absolutely!  Its done all the time!

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

This message was posted by a user wishing to remain anonymous

Thank you!
Original Message:
Sent: 17-May-2022 20:34
From: Narayan Rao
Subject: IB update timing

Absolutely!  Its done all the time!

------------------------------
GRSAOnline

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

It is absolutely reasonable. The idea of the annual review is to assure that it happens, but submitting a new version annually is totally arbitrary if there are reasons that it doesn't need to be updated or, as in your case, there are reasons to delay the submission.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

This message was posted by a user wishing to remain anonymous

Thank you, Dr. Park.
Original Message:
Sent: 18-May-2022 08:10
From: Glen Park
Subject: IB update timing

It is absolutely reasonable. The idea of the annual review is to assure that it happens, but submitting a new version annually is totally arbitrary if there are reasons that it doesn't need to be updated or, as in your case, there are reasons to delay the submission.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...

Also, the requirement is to review the IB annually which includes documentation that a review is conducted. If at the time of review, if no significant change is required due to no new safety, non clinical or clinical information and an IB update is not done you have it documented. I agree with the other advise, submit IB and protocol amendment together if IB is updated. Don't forget your annual report timing in your strategy.  Always good to connect with FDA PM. Lastly, make sure your SOP on IB generation, review and revision is clear on process, timing, and submission. Your GCP QA rep and RA rep are critical inputs to the process. 

Best,  

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 18-May-2022 08:10
From: Glen Park
Subject: IB update timing

It is absolutely reasonable. The idea of the annual review is to assure that it happens, but submitting a new version annually is totally arbitrary if there are reasons that it doesn't need to be updated or, as in your case, there are reasons to delay the submission.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 17-May-2022 16:05
From: Anonymous Member
Subject: IB update timing

This message was posted by a user wishing to remain anonymous

I am aware that a Sponsor must perform an IB review at least annually (more frequently when needed) to ensure it remains updated.

An IB update was last submitted to an IND in July 2021.  It is currently being updated for submission to the same IND in July 2022.  Nearly concurrently, a significant protocol amendment is being prepared (currently targeted for completion 1-2 months after the IB update).  Is it reasonable to request that the IB update and protocol amendment be submitted to the IND at the same time, even though this means 13-14 months would have transpired between the last two IB updates?

I seem to recall doing something like this in the past with a priori agreement via e-mail from an FDA regulatory project manager.

Is this reasonable?  Opinions?

Thank you in advance...