Regulatory Open Forum

Good Morning,

I have always been of the opinion that Section 2.3 QOS was optional in an IND especially if you are providing a well developed Module 3.  Not only did I hold this opinion for practical reasons but I also thought I was supported by a guidance for industry that said the same thing.

I can't find this guidance!  Can anyone point me to the FDA guidance (archived or current) that supports the fact that a CMC 2.3 QOS is not absolutely necessary in an IND?

Thanks,

-------------------------------------------
RL Johnson, MSc, RAC
Manager, Global Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------

Good morning,

I have always provided a complete Module 2 including QOS for IND.  I went to a course for converting IND intoe CTD format and Item 7 was to be module 3 and module 2 QOS.  So I will be very interested if there is a guideline that specifies if QOS is needed or not.
Thanks
-------------------------------------------
Catherine Bernard ScD
Pres
International Regulatory Affairs Services Inc
Highlands Ranch CO
United States
-------------------------------------------






Original Message:
Sent: 02-15-2012 11:43
From: RL Johnson
Subject: To QOS or not to QOS in an IND

Good Morning,

I have always been of the opinion that Section 2.3 QOS was optional in an IND especially if you are providing a well developed Module 3.  Not only did I hold this opinion for practical reasons but I also thought I was supported by a guidance for industry that said the same thing.

I can't find this guidance!  Can anyone point me to the FDA guidance (archived or current) that supports the fact that a CMC 2.3 QOS is not absolutely necessary in an IND?

Thanks,

-------------------------------------------
RL Johnson, MSc, RAC
Manager, Global Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------

FYI:

If I recall correctly, FDA reviewer was stating the following:

Module 2 (QOS) is the basis for the Question-based Review (QbR) used by the Office of Generic Drugs (OGD).

For Phase 1 INDs
-Module 3 without QOS is acceptable.
-Don't submit everything in the QOS.

-------------------------------------------
David Lim, Ph.D., RAC, ASQ-CQA
Chairman and CEO
www.regulatorydoctor.com
Floyd VA
United States
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Original Message:
Sent: 02-16-2012 10:19
From: Catherine Bernard
Subject: To QOS or not to QOS in an IND


Good morning,

I have always provided a complete Module 2 including QOS for IND.  I went to a course for converting IND intoe CTD format and Item 7 was to be module 3 and module 2 QOS.  So I will be very interested if there is a guideline that specifies if QOS is needed or not.
Thanks
-------------------------------------------
Catherine Bernard ScD
Pres
International Regulatory Affairs Services Inc
Highlands Ranch CO
United States
-------------------------------------------






Original Message:
Sent: 02-15-2012 11:43
From: RL Johnson
Subject: To QOS or not to QOS in an IND

Good Morning,

I have always been of the opinion that Section 2.3 QOS was optional in an IND especially if you are providing a well developed Module 3.  Not only did I hold this opinion for practical reasons but I also thought I was supported by a guidance for industry that said the same thing.

I can't find this guidance!  Can anyone point me to the FDA guidance (archived or current) that supports the fact that a CMC 2.3 QOS is not absolutely necessary in an IND?

Thanks,

-------------------------------------------
RL Johnson, MSc, RAC
Manager, Global Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------

The eCTD presentation section of the FDA's web page on electronic submissions is a gold mine of information.  I recently found a presentation that said the opposite, that you could submit a QOS without any information in Module 3, but I can no longer find that one.  Instead I found 3 presentations that support your proposal:

This eCTD presentation says you can use Module 3 without the QOS (page 4):

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM229662.pdf

 And so does this one (slide 27):

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM229695.pdf

 And this one (slide 24):

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM236409.pdf

 -------------------------------------------
Jamie Robinson RAC
Manager, CMC Regulatory Affairs
Cardiome Pharma Corp
Vancouver BC
Canada
-------------------------------------------

Original Message:
Sent: 02-15-2012 11:43
From: RL Johnson
Subject: To QOS or not to QOS in an IND

Good Morning,

I have always been of the opinion that Section 2.3 QOS was optional in an IND especially if you are providing a well developed Module 3.  Not only did I hold this opinion for practical reasons but I also thought I was supported by a guidance for industry that said the same thing.

I can't find this guidance!  Can anyone point me to the FDA guidance (archived or current) that supports the fact that a CMC 2.3 QOS is not absolutely necessary in an IND?

Thanks,

-------------------------------------------
RL Johnson, MSc, RAC
Manager, Global Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------

Hi,
There is no requirement for an IND QOS, since IND requirements are stated in US 21CFR312 whereas the CTD (of which the QOS is part), is an ICH topic (and to the US, guidance). That being said, I'd recommend talk to your FDA review division about what they'd wish to see in your IND in CTD format. I included a QOS for a project whose medicinal product was 2 products already approved for other indications. We cited the product labels for the other indications in the QOS. (FDA accepted that, so we never filed M3.)
Hope this helps!
Sandy
-------------------------------------------
Sandra Hecker RAC
President
Hecker & Associates LLC
Arlington VA
United States
-------------------------------------------






Original Message:
Sent: 02-15-2012 11:43
From: RL Johnson
Subject: To QOS or not to QOS in an IND

Good Morning,

I have always been of the opinion that Section 2.3 QOS was optional in an IND especially if you are providing a well developed Module 3.  Not only did I hold this opinion for practical reasons but I also thought I was supported by a guidance for industry that said the same thing.

I can't find this guidance!  Can anyone point me to the FDA guidance (archived or current) that supports the fact that a CMC 2.3 QOS is not absolutely necessary in an IND?

Thanks,

-------------------------------------------
RL Johnson, MSc, RAC
Manager, Global Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------

Thank you to the team and my peers for insightful discussion on this gray/grey area.

Summary to my question

• No regulatory language prescribes that 2.3 QOS must be filled out (Other than generics QbR)
• Inclusion or exclusion of the 2.3 QOS is also valid discussion point with the FDA if questions still exist

Thanks again,
RL

-------------------------------------------
RL Johnson RAC
Manager, Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------






Original Message:
Sent: 02-16-2012 16:08
From: Sandra Hecker
Subject: To QOS or not to QOS in an IND


Hi,
There is no requirement for an IND QOS, since IND requirements are stated in US 21CFR312 whereas the CTD (of which the QOS is part), is an ICH topic (and to the US, guidance). That being said, I'd recommend talk to your FDA review division about what they'd wish to see in your IND in CTD format. I included a QOS for a project whose medicinal product was 2 products already approved for other indications. We cited the product labels for the other indications in the QOS. (FDA accepted that, so we never filed M3.)
Hope this helps!
Sandy
-------------------------------------------
Sandra Hecker RAC
President
Hecker & Associates LLC
Arlington VA
United States
-------------------------------------------






Original Message:
Sent: 02-15-2012 11:43
From: RL Johnson
Subject: To QOS or not to QOS in an IND

Good Morning,

I have always been of the opinion that Section 2.3 QOS was optional in an IND especially if you are providing a well developed Module 3.  Not only did I hold this opinion for practical reasons but I also thought I was supported by a guidance for industry that said the same thing.

I can't find this guidance!  Can anyone point me to the FDA guidance (archived or current) that supports the fact that a CMC 2.3 QOS is not absolutely necessary in an IND?

Thanks,

-------------------------------------------
RL Johnson, MSc, RAC
Manager, Global Regulatory Affairs
IKARIA
Port Allen LA
United States
-------------------------------------------