Regulatory Open Forum

If the IP is available commercially and you intend to purchase it and use it as is, then a reference to the USPI is usually fine.  This assumes that you are not the 'owner' of the IND/NDA.  In order to cross reference an IND/NDA you need permission of the owner of the information, which is unlikely unless you have an agreement with them for such sharing of information.  Also, if you intend to modify/change or alter the commercial product in any way to use it in the study (i.e., blinding, repackaging) then you will need to provide the additional information on any such changes.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 09-Sep-2020 17:12
From: Vasundhara Pathak
Subject: Cross reference IND for commercial product

Hello All,

For a planned study which includes a commercially available product as an IMP do we need to cross refer to its parent IND during study IND submission? Or can USPI be considered for the cross reference information? 

Thanks in advance! 

Original Message:
Sent: 9/10/2020 9:57:00 AM
From: Michael Hamrell
Subject: RE: Cross reference IND for commercial product

If the IP is available commercially and you intend to purchase it and use it as is, then a reference to the USPI is usually fine.  This assumes that you are not the 'owner' of the IND/NDA.  In order to cross reference an IND/NDA you need permission of the owner of the information, which is unlikely unless you have an agreement with them for such sharing of information.  Also, if you intend to modify/change or alter the commercial product in any way to use it in the study (i.e., blinding, repackaging) then you will need to provide the additional information on any such changes.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 09-Sep-2020 17:12
From: Vasundhara Pathak
Subject: Cross reference IND for commercial product

Hello All,

For a planned study which includes a commercially available product as an IMP do we need to cross refer to its parent IND during study IND submission? Or can USPI be considered for the cross reference information? 

Thanks in advance! 

You can use the commercially available drug outside of the approved labeling as long as it is under an IND (since the use is unapproved).

whether or not they can make label changes based on the results of the study will determined by FDA if they submit a supplemental application with the data and it supports the claim.  If this is your study they would not have access to the data to submit to FDA unless you share it with them.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 10-Sep-2020 10:10
From: Vasundhara Pathak
Subject: Cross reference IND for commercial product

Dear Michael,

Thanks very much for your response.

Does that mean a commercially available drug can be used outside its approved indication in a clinical study of just refer to USPI. 

Yes the study sponsor is not the owner of the product IND. 

If this drug is being used in combination with sponsors' drug, can sponsor make label change to it's drug in future based on study results in this combination? 

Many thanks!

Original Message:
Sent: 9/10/2020 9:57:00 AM
From: Michael Hamrell
Subject: RE: Cross reference IND for commercial product

If the IP is available commercially and you intend to purchase it and use it as is, then a reference to the USPI is usually fine.  This assumes that you are not the 'owner' of the IND/NDA.  In order to cross reference an IND/NDA you need permission of the owner of the information, which is unlikely unless you have an agreement with them for such sharing of information.  Also, if you intend to modify/change or alter the commercial product in any way to use it in the study (i.e., blinding, repackaging) then you will need to provide the additional information on any such changes.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 09-Sep-2020 17:12
From: Vasundhara Pathak
Subject: Cross reference IND for commercial product

Hello All,

For a planned study which includes a commercially available product as an IMP do we need to cross refer to its parent IND during study IND submission? Or can USPI be considered for the cross reference information? 

Thanks in advance! 

Original Message:
Sent: 9/10/2020 10:18:00 AM
From: Michael Hamrell
Subject: RE: Cross reference IND for commercial product

You can use the commercially available drug outside of the approved labeling as long as it is under an IND (since the use is unapproved).

whether or not they can make label changes based on the results of the study will determined by FDA if they submit a supplemental application with the data and it supports the claim.  If this is your study they would not have access to the data to submit to FDA unless you share it with them.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 10-Sep-2020 10:10
From: Vasundhara Pathak
Subject: Cross reference IND for commercial product

Dear Michael,

Thanks very much for your response.

Does that mean a commercially available drug can be used outside its approved indication in a clinical study of just refer to USPI. 

Yes the study sponsor is not the owner of the product IND. 

If this drug is being used in combination with sponsors' drug, can sponsor make label change to it's drug in future based on study results in this combination? 

Many thanks!

Original Message:
Sent: 9/10/2020 9:57:00 AM
From: Michael Hamrell
Subject: RE: Cross reference IND for commercial product

If the IP is available commercially and you intend to purchase it and use it as is, then a reference to the USPI is usually fine.  This assumes that you are not the 'owner' of the IND/NDA.  In order to cross reference an IND/NDA you need permission of the owner of the information, which is unlikely unless you have an agreement with them for such sharing of information.  Also, if you intend to modify/change or alter the commercial product in any way to use it in the study (i.e., blinding, repackaging) then you will need to provide the additional information on any such changes.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 09-Sep-2020 17:12
From: Vasundhara Pathak
Subject: Cross reference IND for commercial product

Hello All,

For a planned study which includes a commercially available product as an IMP do we need to cross refer to its parent IND during study IND submission? Or can USPI be considered for the cross reference information? 

Thanks in advance!