Regulatory Open Forum

Hello, 

We have a sponsor who is changing their address (legal entity and phone number unchanged).  How is this submitted to FDA?  Can it be done during another amendment submission?

Besides the 1572, what forms are needed?

Thanks for your help.

------------------------------
Theresa Shalaby
Director, Regulatory Affairs
Thompsons Station TN
United States
------------------------------

Hello Theresa,

It sounds like you are inquiring about the IND Sponsor change. If so, submit Form 1571, a cover letter, and a Module 1, Administrative change under  1.3.1.1 Change of Address or Corporate Name via the gateway.
I also recommend sending a courtesy email to your FDA PM before filing this IND submission informing of the address change. 




------------------------------
Kristina Fink
Manager, Regulatory Affairs Strategy
Madison WI
United States
------------------------------

Original Message:
Sent: 21-Sep-2022 12:51
From: Theresa Shalaby
Subject: Sponsor Address Change to FDA

Hello,

We have a sponsor who is changing their address (legal entity and phone number unchanged).  How is this submitted to FDA?  Can it be done during another amendment submission?

Besides the 1572, what forms are needed?

Thanks for your help.

------------------------------
Theresa Shalaby
Director, Regulatory Affairs
Thompsons Station TN
United States
------------------------------

Hi Kristin,  Thank you so much.  Should this or can this wait until another amendment is ready, or annual  review, or should it go out right away?  I know the FDA prefers less frequent submission, but we want to make sure this could wait to be bundled with another communication with FDA. Thanks again~

------------------------------
Theresa Shalaby
Director, Regulatory Affairs
Thompsons Station TN
United States
------------------------------

Original Message:
Sent: 22-Sep-2022 10:35
From: Kristina Fink
Subject: Sponsor Address Change to FDA

Hello Theresa,

It sounds like you are inquiring about the IND Sponsor change. If so, submit Form 1571, a cover letter, and a Module 1, Administrative change under  1.3.1.1 Change of Address or Corporate Name via the gateway.
I also recommend sending a courtesy email to your FDA PM before filing this IND submission informing of the address change.




------------------------------
Kristina Fink
Manager, Regulatory Affairs Strategy
Madison WI
United States

Original Message:
Sent: 21-Sep-2022 12:51
From: Theresa Shalaby
Subject: Sponsor Address Change to FDA

Hello,

We have a sponsor who is changing their address (legal entity and phone number unchanged).  How is this submitted to FDA?  Can it be done during another amendment submission?

Besides the 1572, what forms are needed?

Thanks for your help.

------------------------------
Theresa Shalaby
Director, Regulatory Affairs
Thompsons Station TN
United States
------------------------------

In my experience, we have submitted the address change as soon as possible. If you can bundle it with other submission - great, if not, I would recommend submitting as stand alone.

------------------------------
Kristina Fink
Manager, Regulatory Affairs Strategy
Madison WI
United States
------------------------------

Original Message:
Sent: 22-Sep-2022 13:54
From: Theresa Shalaby
Subject: Sponsor Address Change to FDA

Hi Kristin,  Thank you so much.  Should this or can this wait until another amendment is ready, or annual  review, or should it go out right away?  I know the FDA prefers less frequent submission, but we want to make sure this could wait to be bundled with another communication with FDA. Thanks again~

------------------------------
Theresa Shalaby
Director, Regulatory Affairs
Thompsons Station TN
United States

Original Message:
Sent: 22-Sep-2022 10:35
From: Kristina Fink
Subject: Sponsor Address Change to FDA

Hello Theresa,

It sounds like you are inquiring about the IND Sponsor change. If so, submit Form 1571, a cover letter, and a Module 1, Administrative change under  1.3.1.1 Change of Address or Corporate Name via the gateway.
I also recommend sending a courtesy email to your FDA PM before filing this IND submission informing of the address change.




------------------------------
Kristina Fink
Manager, Regulatory Affairs Strategy
Madison WI
United States

Original Message:
Sent: 21-Sep-2022 12:51
From: Theresa Shalaby
Subject: Sponsor Address Change to FDA

Hello,

We have a sponsor who is changing their address (legal entity and phone number unchanged).  How is this submitted to FDA?  Can it be done during another amendment submission?

Besides the 1572, what forms are needed?

Thanks for your help.

------------------------------
Theresa Shalaby
Director, Regulatory Affairs
Thompsons Station TN
United States
------------------------------