Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful. 

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

Dear Anonymous,

The date on your acknowledgment receipts from the ESG is the date that FDA received your IND. This date is the start of the 30 day time clock (Day 0).

I wouldn't worry yet about not receiving the acknowledgment letter as it has only been 1 week. You may wish to reach out to your Regulatory Project Manager just to be sure that it has been received.

Thank you.

Sincerely yours, Suzanne

------------------------------
Suzanne M. Sensabaugh, MS, MBA
President and Principal Consultant
HartmannWillner LLC
100 M Street SE
Suite 600
Washington, DC 20003
Phone: 202-749-8616

www.hw-fda.com
------------------------------

Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

​For clarity, 21 CFR 312.40 (b) (1) specifies that the IND going in effect 30 days after FDA receives the IND unless notified by FDA that the IND is on hold.  As long as you document the date of receipt of the IND, by regulation, you are allowed to proceed.  However, its always prudent to confirm that FDA does not intend to place a hold for safety or related issues.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States
------------------------------

Original Message:
Sent: 31-Oct-2018 07:43
From: Suzanne Sensabaugh
Subject: IND acknowledgement letter

Dear Anonymous,

The date on your acknowledgment receipts from the ESG is the date that FDA received your IND. This date is the start of the 30 day time clock (Day 0).

I wouldn't worry yet about not receiving the acknowledgment letter as it has only been 1 week. You may wish to reach out to your Regulatory Project Manager just to be sure that it has been received.

Thank you.

Sincerely yours, Suzanne

------------------------------
Suzanne M. Sensabaugh, MS, MBA
President and Principal Consultant
HartmannWillner LLC
100 M Street SE
Suite 600
Washington, DC 20003
Phone: 202-749-8616

www.hw-fda.com

Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

I have found the timing and actuality of IND filing letters to be inconsistent among Divisions and PMs.  In some cases, I have had to contact the PM to confirm that it was actually under review - people get nervous not knowing.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

I agree with Glen.
I would say the 30 days clock start ticking when the submission is with the FDA Review team.

------------------------------
Artur Shchukin
New York NY
United States
------------------------------

Original Message:
Sent: 31-Oct-2018 10:28
From: Glen Park
Subject: IND acknowledgement letter

I have found the timing and actuality of IND filing letters to be inconsistent among Divisions and PMs.  In some cases, I have had to contact the PM to confirm that it was actually under review - people get nervous not knowing.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

This message was posted by a user wishing to remain anonymous

​It usually takes about 2 weeks to receive the hard copy acknowledgement in mail (assuming that's what you are referring to). The 30-day clock begins from the date of submission. There shouldn't be any reason for concern since the automated submission confirmation was received.
Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

I agree with Suzanne and Anon. The ESG acknowledgement of receipt (auto-generated and on date of submission) is suffice and that's when the 30-day review clock starts.

------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------

Original Message:
Sent: 31-Oct-2018 10:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

​It usually takes about 2 weeks to receive the hard copy acknowledgement in mail (assuming that's what you are referring to). The 30-day clock begins from the date of submission. There shouldn't be any reason for concern since the automated submission confirmation was received.
Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

I wouldn't be too alarmed. Not surprised you haven't received as its only been a week.  For our last IND, we never even received an acknowledgement letter.  I think some FDA divisions don't even send acknowledgment letters anymore.  You can email your FDA project manager to confirm.  And yes - the 30 day clock starts upon receipt of the IND.
Tom
Chicago

------------------------------
Tom
Chicago
------------------------------

Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?

If you have the automatic acknowledgement letter from CDER/CBER then it was received; no need to worry. 

You should receive the acknowledgement with 7-10 days and if you don't then I suggest calling the Division and asking about it but don't be surprised if they won't answer you and ask you to send the question via secure email - but the phone call will probably get you your assigned project manager and email so you can start communicating with your Project Manager.

------------------------------
Meredith Brown-Tuttle, RAC, FRAPS
President
Regulatorium
Santa Clara CA
United States
------------------------------

Original Message:
Sent: 30-Oct-2018 13:05
From: Anonymous Member
Subject: IND acknowledgement letter

This message was posted by a user wishing to remain anonymous

Hello,

We recently submitted an initial IND application a week ago and also emailed the FDA project manager confirming submission. The publishers received the automated confirmation that the submission was successful.

However, we have not received an IND acknowledgement letter from the FDA stating that the IND submission was received. Has the 30-day review clock begun already (from the date of submission)? And is it a matter for concern if the IND acknowledgement of receipt letter has not been received yet (a week later)?