Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

For the 30-day review period of IND, usually at which day do you hear from FDA with the information request? Is it D21, D22, D23 after the submission? And how many hours or days (24 hours? 48 hours?) do you have for the response?

Thank you!

Hi,
My experience is FDA usually send out IR around week 3~week 4, and request response within 1-3 days depends on how many days left till day 30.



Original Message:
Sent: 01-Dec-2021 17:41
From: Anonymous Member
Subject: IND - information request from FDA - at what day?

This message was posted by a user wishing to remain anonymous

Hello,

For the 30-day review period of IND, usually at which day do you hear from FDA with the information request? Is it D21, D22, D23 after the submission? And how many hours or days (24 hours? 48 hours?) do you have for the response?

Thank you!

This message was posted by a user wishing to remain anonymous

Any day before 30 day review deadline!
Original Message:
Sent: 01-Dec-2021 17:41
From: Anonymous Member
Subject: IND - information request from FDA - at what day?

This message was posted by a user wishing to remain anonymous

Hello,

For the 30-day review period of IND, usually at which day do you hear from FDA with the information request? Is it D21, D22, D23 after the submission? And how many hours or days (24 hours? 48 hours?) do you have for the response?

Thank you!

This message was posted by a user wishing to remain anonymous

Yes, agree with previous poster, my experience has been to hear around day 21 or so.  The request response can also be dependent on the type of request.  If it is a simple addition to the clinical protocol, the deadline may be COB of that same day.  If it requires an extensive response then usually the response time is longer.  

In my experience, the FDA is usually willing to extend the request response timeline for valid excuses (need to obtain the info from a 3rd party, sponsor is tied up with surgery, etc).  But, as mentioned below, this is also contingent on how close it is to the 30 day expiration.
Original Message:
Sent: 01-Dec-2021 17:41
From: Anonymous Member
Subject: IND - information request from FDA - at what day?

This message was posted by a user wishing to remain anonymous

Hello,

For the 30-day review period of IND, usually at which day do you hear from FDA with the information request? Is it D21, D22, D23 after the submission? And how many hours or days (24 hours? 48 hours?) do you have for the response?

Thank you!