Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

FDA has provided some comments for consideration in the Study May Proceed Letter for an IND application. Do you generally submit a response document to FDA for comments in the Study May Proceed Letter? My understanding is those comments are just for consideration and a formal response document is not required.

Thanks in advance!

You are correct that a formal response is not required. That doesn't mean that you shouldn't take them seriously - or at least seriously enough to consider incorporating them into your program if they make sense. It is simply advice and not a requirement.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 08-Nov-2020 10:46
From: Anonymous Member
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

This message was posted by a user wishing to remain anonymous

Hello All,

FDA has provided some comments for consideration in the Study May Proceed Letter for an IND application. Do you generally submit a response document to FDA for comments in the Study May Proceed Letter? My understanding is those comments are just for consideration and a formal response document is not required.

Thanks in advance!

This message was posted by a user wishing to remain anonymous

Thanks for your response, Glen!
Original Message:
Sent: 10-Nov-2020 07:38
From: Glen Park
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

You are correct that a formal response is not required. That doesn't mean that you shouldn't take them seriously - or at least seriously enough to consider incorporating them into your program if they make sense. It is simply advice and not a requirement.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 08-Nov-2020 10:46
From: Anonymous Member
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

This message was posted by a user wishing to remain anonymous

Hello All,

FDA has provided some comments for consideration in the Study May Proceed Letter for an IND application. Do you generally submit a response document to FDA for comments in the Study May Proceed Letter? My understanding is those comments are just for consideration and a formal response document is not required.

Thanks in advance!

I agree with Glen.  Any comments from the FDA should be taken into consideration and you should revise your protocol/plan if considered appropriate.  Of course if you amend the protocol then this should be submitted as an 'IND amendment: change in protocol'.

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Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
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Original Message:
Sent: 10-Nov-2020 08:03
From: Anonymous Member
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

This message was posted by a user wishing to remain anonymous

Thanks for your response, Glen!
Original Message:
Sent: 10-Nov-2020 07:38
From: Glen Park
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

You are correct that a formal response is not required. That doesn't mean that you shouldn't take them seriously - or at least seriously enough to consider incorporating them into your program if they make sense. It is simply advice and not a requirement.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 08-Nov-2020 10:46
From: Anonymous Member
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

This message was posted by a user wishing to remain anonymous

Hello All,

FDA has provided some comments for consideration in the Study May Proceed Letter for an IND application. Do you generally submit a response document to FDA for comments in the Study May Proceed Letter? My understanding is those comments are just for consideration and a formal response document is not required.

Thanks in advance!

It depends on what kind of recommendations provided in your FDA letter. You cannot completely ignore them and be silent with no response! I would strongly respond with what you agree to incorporate and what you don't wish to incorporate with rationale. For example, there may be a recommendation that you should submit data for review after single ascending dose part of the protocol is completed prior to proceeding with your multiple ascending dose part, or you did not submit the assay to measure the free antibody that may be available in vivo after dosing begins etc.....

You should respond in a timely fashion for the above.


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GRSAOnline
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Original Message:
Sent: 08-Nov-2020 10:46
From: Anonymous Member
Subject: Response to FDA Comments for Consideration in Study May Proceed Letter

This message was posted by a user wishing to remain anonymous

Hello All,

FDA has provided some comments for consideration in the Study May Proceed Letter for an IND application. Do you generally submit a response document to FDA for comments in the Study May Proceed Letter? My understanding is those comments are just for consideration and a formal response document is not required.

Thanks in advance!