Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US. 

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.

That is a tough one. Without involvement of the other manufacturer, I do not know how to include an investigational product for which you don't have authorization from the IND holder in a clinical trial, or manufacturing yourself and opening your own IND.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 08-Apr-2019 18:52
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US.

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.

This message was posted by a user wishing to remain anonymous

Hi Glen, 

Thanks for your reply. 

If you're partnering with said company on a collaborative clinical trial, would if be sufficient to include a letter of cross-reference in your company's IND (with their permission), to their IND for information pertaining to their clinical product?
Original Message:
Sent: 09-Apr-2019 09:11
From: Glen Park
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

That is a tough one. Without involvement of the other manufacturer, I do not know how to include an investigational product for which you don't have authorization from the IND holder in a clinical trial, or manufacturing yourself and opening your own IND.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 08-Apr-2019 18:52
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US.

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.

If you are partnering and using the partner manufacturer's drug in a study under your IND, a letter of authorization from the partner to reference their IND would be appropriate. The question is whether the partner should also submit the protocol to their IND to facilitate safety reporting, which would be required under their IND. Other questions to consider is the potential impact of the data on efficacy of their product, etc.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 09-Apr-2019 11:06
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

Hi Glen,

Thanks for your reply.

If you're partnering with said company on a collaborative clinical trial, would if be sufficient to include a letter of cross-reference in your company's IND (with their permission), to their IND for information pertaining to their clinical product?
Original Message:
Sent: 09-Apr-2019 09:11
From: Glen Park
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

That is a tough one. Without involvement of the other manufacturer, I do not know how to include an investigational product for which you don't have authorization from the IND holder in a clinical trial, or manufacturing yourself and opening your own IND.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 08-Apr-2019 18:52
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US.

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.

FDA has issued DRAFT Guidance Investigational IVDs in Clinical Investigations of Therapeutic Products Guidance for Industry. While the device you are considering might not be strictly an invitro diagnostic device, the reasoning and requirements set forth in the draft guidance could have useful application to your situation by analogy.

------------------------------
W Thomas Koch
New York NY
United States
------------------------------

Original Message:
Sent: 08-Apr-2019 18:52
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US.

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.

This message was posted by a user wishing to remain anonymous

Assuming your question is pertaining to drugs/biologics since you mention an IND - If both investigational products (IP) have an active US IND, then labeling follows 21 CFR 312.6. The packaging would be as defined in the respective INDs. As far as import is concerned there should be no additional requirements as long as the IND is in good standing and the product complies with packaging / labeling requirements under the IND. If you've previously imported this pdt into the US, the same documentation would apply, except the IND you would now refer to would be your own as part of the importation documentation.

All this of course should be preceded by the following - your US clinical trial protocol has the ex-US IP included in it, and you have filed an IND cross-reference letter of access from the ex-US pdt manufacturer's IND to your IND, provided the ex-US pdt Investigator's Brochure to your investigators/IRB and your IND. Plus you should also have built in safety reporting requirements for the ex-US pdt, i.e. you need to report any AEs related to that pdt to its manufacturer, in addition of course to your IND, in accordance with the regulations.

This is all I can think of for now.  All this is just based on my experience where we provide our IP to other groups for use in their clinical trials of their IP (but mostly in the US).

Hopefully this helps.

Original Message:
Sent: 11-Apr-2019 16:29
From: W Thomas Koch
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

FDA has issued DRAFT Guidance Investigational IVDs in Clinical Investigations of Therapeutic Products Guidance for Industry. While the device you are considering might not be strictly an invitro diagnostic device, the reasoning and requirements set forth in the draft guidance could have useful application to your situation by analogy.

------------------------------
W Thomas Koch
New York NY
United States

Original Message:
Sent: 08-Apr-2019 18:52
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US.

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.

Original Message:
Sent: 12-Apr-2019 10:53
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

Assuming your question is pertaining to drugs/biologics since you mention an IND - If both investigational products (IP) have an active US IND, then labeling follows 21 CFR 312.6. The packaging would be as defined in the respective INDs. As far as import is concerned there should be no additional requirements as long as the IND is in good standing and the product complies with packaging / labeling requirements under the IND. If you've previously imported this pdt into the US, the same documentation would apply, except the IND you would now refer to would be your own as part of the importation documentation.

All this of course should be preceded by the following - your US clinical trial protocol has the ex-US IP included in it, and you have filed an IND cross-reference letter of access from the ex-US pdt manufacturer's IND to your IND, provided the ex-US pdt Investigator's Brochure to your investigators/IRB and your IND. Plus you should also have built in safety reporting requirements for the ex-US pdt, i.e. you need to report any AEs related to that pdt to its manufacturer, in addition of course to your IND, in accordance with the regulations.

This is all I can think of for now.  All this is just based on my experience where we provide our IP to other groups for use in their clinical trials of their IP (but mostly in the US).

Hopefully this helps.

Original Message:
Sent: 11-Apr-2019 16:29
From: W Thomas Koch
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

FDA has issued DRAFT Guidance Investigational IVDs in Clinical Investigations of Therapeutic Products Guidance for Industry. While the device you are considering might not be strictly an invitro diagnostic device, the reasoning and requirements set forth in the draft guidance could have useful application to your situation by analogy.

------------------------------
W Thomas Koch
New York NY
United States

Original Message:
Sent: 08-Apr-2019 18:52
From: Anonymous Member
Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations

This message was posted by a user wishing to remain anonymous

I'm looking for advice regarding the regulatory considerations pertaining to the inclusion of another company's investigational product in a clinical trial in the US.

If the investigational product is manufactured ex-US, but that product has a US IND, what's the best approach from an importation, packaging and labeling perspective?

Thanks.