Regulatory Open Forum

Dear community,

My company is planning to submit an IND early next year. We are a european company and I was wondering if we need an US Agent. And if yes, for what purpose precisely ?
Sorry for my naive question but I am a new one in the RA field.

I would appreciate your help.

Thanks a lot.
And take care.

Nathalie

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Hi Nathalie,

FDA requires foreign firms to have a US Agent as the contact person. Usually the agent manages communications between the FDA and the firm, but I have in the past served as the agent and the firm managed the submissions and correspondence without my involvement. On the other hand, with INDs filed as eCTD through the ESG also requires a contact in the US for any technical issues. The US location is simply to facilitate timely communications - I think so that they don't have to think about time zone differences if they are trying to contact the firm.

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

Original Message:
Sent: 20-Nov-2020 08:58
From: Nathalie DELESQUE TOUCHARD
Subject: US Agent for INF filing

Dear community,

My company is planning to submit an IND early next year. We are a european company and I was wondering if we need an US Agent. And if yes, for what purpose precisely ?
Sorry for my naive question but I am a new one in the RA field.

I would appreciate your help.

Thanks a lot.
And take care.

Nathalie

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Thank you so much for the clarification.
Very appreciable !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Original Message:
Sent: 20-Nov-2020 10:42
From: Glen Park
Subject: US Agent for INF filing

Hi Nathalie,

FDA requires foreign firms to have a US Agent as the contact person. Usually the agent manages communications between the FDA and the firm, but I have in the past served as the agent and the firm managed the submissions and correspondence without my involvement. On the other hand, with INDs filed as eCTD through the ESG also requires a contact in the US for any technical issues. The US location is simply to facilitate timely communications - I think so that they don't have to think about time zone differences if they are trying to contact the firm.

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

Original Message:
Sent: 20-Nov-2020 08:58
From: Nathalie DELESQUE TOUCHARD
Subject: US Agent for INF filing

Dear community,

My company is planning to submit an IND early next year. We are a european company and I was wondering if we need an US Agent. And if yes, for what purpose precisely ?
Sorry for my naive question but I am a new one in the RA field.

I would appreciate your help.

Thanks a lot.
And take care.

Nathalie

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------