Regulatory Open Forum

Hi All,
What's the practice for placing Placebo information in IND CTD documents; 3R or 3P?
Since there's no clear direction or suggestions from the FDA, what practice would be best possible and what would be the technical justification for that.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------

Dear Pallavi,

The matching placebo is considered an investigational product (comparator) and belongs in 3P as part of material being investigated during the clinical trial.  In accordance with Guidance for Industry M4Q: The CTD Quality 3R is for additional DS and DP information specific to each region.

Best,

Dar​

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 27-Jun-2022 12:33
From: Pallavi Sharma
Subject: Placebo information in IND -CTD document

Hi All,
What's the practice for placing Placebo information in IND CTD documents; 3R or 3P?
Since there's no clear direction or suggestions from the FDA, what practice would be best possible and what would be the technical justification for that.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------

Thanks, Dar,
I agree with your absolutely.
wanted to know what other practices have been followed.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------

Original Message:
Sent: 27-Jun-2022 13:53
From: Darlene Rosario
Subject: Placebo information in IND -CTD document

Dear Pallavi,

The matching placebo is considered an investigational product (comparator) and belongs in 3P as part of material being investigated during the clinical trial.  In accordance with Guidance for Industry M4Q: The CTD Quality 3R is for additional DS and DP information specific to each region.

Best,

Dar​

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States

Original Message:
Sent: 27-Jun-2022 12:33
From: Pallavi Sharma
Subject: Placebo information in IND -CTD document

Hi All,
What's the practice for placing Placebo information in IND CTD documents; 3R or 3P?
Since there's no clear direction or suggestions from the FDA, what practice would be best possible and what would be the technical justification for that.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------

Dear Pallavi,
The matching placebo of the active drug product is considered as an Investigational Medicinal Product. The corresponding matching placebo M3 information can be submitted as a separate 3.2.P sections similar to the active drug product. This is the practice most of the companies follow in the US and also Ex-US countries. It will be accepted by the HA and no issues at all.

Good Luck!
Vj

------------------------------
Vijayalakshmi Ramanan RAC
Director-Global Regulatory CMC
Atea Pharmaceuticals Inc,
Boston, MA, United States
------------------------------

Original Message:
Sent: 27-Jun-2022 13:53
From: Darlene Rosario
Subject: Placebo information in IND -CTD document

Dear Pallavi,

The matching placebo is considered an investigational product (comparator) and belongs in 3P as part of material being investigated during the clinical trial.  In accordance with Guidance for Industry M4Q: The CTD Quality 3R is for additional DS and DP information specific to each region.

Best,

Dar​

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States

Original Message:
Sent: 27-Jun-2022 12:33
From: Pallavi Sharma
Subject: Placebo information in IND -CTD document

Hi All,
What's the practice for placing Placebo information in IND CTD documents; 3R or 3P?
Since there's no clear direction or suggestions from the FDA, what practice would be best possible and what would be the technical justification for that.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------

Same practice here - we create a 3.2.P - Placebo section. The amount of information in that section depends on the placebo (whether it's purchased commercially, etc.).

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 28-Jun-2022 07:28
From: Vijayalakshmi Ramanan
Subject: Placebo information in IND -CTD document

Dear Pallavi,
The matching placebo of the active drug product is considered as an Investigational Medicinal Product. The corresponding matching placebo M3 information can be submitted as a separate 3.2.P sections similar to the active drug product. This is the practice most of the companies follow in the US and also Ex-US countries. It will be accepted by the HA and no issues at all.

Good Luck!
Vj

------------------------------
Vijayalakshmi Ramanan RAC
Director-Global Regulatory CMC
Atea Pharmaceuticals Inc,
Boston, MA, United States

Original Message:
Sent: 27-Jun-2022 13:53
From: Darlene Rosario
Subject: Placebo information in IND -CTD document

Dear Pallavi,

The matching placebo is considered an investigational product (comparator) and belongs in 3P as part of material being investigated during the clinical trial.  In accordance with Guidance for Industry M4Q: The CTD Quality 3R is for additional DS and DP information specific to each region.

Best,

Dar​

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States

Original Message:
Sent: 27-Jun-2022 12:33
From: Pallavi Sharma
Subject: Placebo information in IND -CTD document

Hi All,
What's the practice for placing Placebo information in IND CTD documents; 3R or 3P?
Since there's no clear direction or suggestions from the FDA, what practice would be best possible and what would be the technical justification for that.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------

Original Message:
Sent: 7/5/2022 9:20:00 AM
From: Rachel Thornton
Subject: RE: Placebo information in IND -CTD document

Same practice here - we create a 3.2.P - Placebo section. The amount of information in that section depends on the placebo (whether it's purchased commercially, etc.).

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 28-Jun-2022 07:28
From: Vijayalakshmi Ramanan
Subject: Placebo information in IND -CTD document

Dear Pallavi,
The matching placebo of the active drug product is considered as an Investigational Medicinal Product. The corresponding matching placebo M3 information can be submitted as a separate 3.2.P sections similar to the active drug product. This is the practice most of the companies follow in the US and also Ex-US countries. It will be accepted by the HA and no issues at all.

Good Luck!
Vj

------------------------------
Vijayalakshmi Ramanan RAC
Director-Global Regulatory CMC
Atea Pharmaceuticals Inc,
Boston, MA, United States

Original Message:
Sent: 27-Jun-2022 13:53
From: Darlene Rosario
Subject: Placebo information in IND -CTD document

Dear Pallavi,

The matching placebo is considered an investigational product (comparator) and belongs in 3P as part of material being investigated during the clinical trial.  In accordance with Guidance for Industry M4Q: The CTD Quality 3R is for additional DS and DP information specific to each region.

Best,

Dar​

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States

Original Message:
Sent: 27-Jun-2022 12:33
From: Pallavi Sharma
Subject: Placebo information in IND -CTD document

Hi All,
What's the practice for placing Placebo information in IND CTD documents; 3R or 3P?
Since there's no clear direction or suggestions from the FDA, what practice would be best possible and what would be the technical justification for that.
Thanks

------------------------------
Pallavi Sharma
Florham Park NJ
United States
------------------------------