Regulatory Open Forum

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

All that information does become "part" of the IND, but you can reference or link it in your NDA electronic submission.
See FDA Form 0356h and the 0356h Instructions. They are on this FDA forms page.
See especially the Form at #30 which is a checklist of 20 items to include in your NDA. It requires a " Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2).
Checklists on FDA marketing forms is my secret weapon for listing what I have to plan for in the years/decades leading up the filing.​
Good luck!

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States
------------------------------

Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

This message was posted by a user wishing to remain anonymous

I would recommend checking with your submission publisher.  At this time, MOST submission software cannot include INTER-application links, meaning you cannot have an active link in your NDA that takes the reviewer to a document in your IND.

For ease of review, I would generally recommend having a stand-alone NDA with all of the relevant reports included in the various modules.  While this information may be available in the IND file, the reviewer would need to close the NDA application and open the IND application in order to review the material.  Personally, I like to make it easy for the reviewer to stay focused during the NDA review process. 

Additionally, while source reports may not have changed, your summaries and/or interpretations in the Module 2 summaries will likely require an update in the NDA compared to any previous versions provided in the IND.  

So, while the IND is an excellent starting material for the building of your NDA, I would recommend looking at your NDA as an independent document that contains all of the information that may be needed to approve your product - until such a time that submission software (including whatever FDA would be using) allows for inter-application links.
Original Message:
Sent: 26-Feb-2022 10:06
From: Andrea Chamblee
Subject: NDA Submission - Resubmit IND Information?

All that information does become "part" of the IND, but you can reference or link it in your NDA electronic submission.
See FDA Form 0356h and the 0356h Instructions. They are on this FDA forms page.
See especially the Form at #30 which is a checklist of 20 items to include in your NDA. It requires a " Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2).
Checklists on FDA marketing forms is my secret weapon for listing what I have to plan for in the years/decades leading up the filing.​
Good luck!

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States

Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

I will check with our Publisher.  Thank you for the advice.  I too like to make it as easy as practical on the reviewer.

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

Original Message:
Sent: 28-Feb-2022 09:17
From: Anonymous Member
Subject: NDA Submission - Resubmit IND Information?

This message was posted by a user wishing to remain anonymous

I would recommend checking with your submission publisher.  At this time, MOST submission software cannot include INTER-application links, meaning you cannot have an active link in your NDA that takes the reviewer to a document in your IND.

For ease of review, I would generally recommend having a stand-alone NDA with all of the relevant reports included in the various modules.  While this information may be available in the IND file, the reviewer would need to close the NDA application and open the IND application in order to review the material.  Personally, I like to make it easy for the reviewer to stay focused during the NDA review process.

Additionally, while source reports may not have changed, your summaries and/or interpretations in the Module 2 summaries will likely require an update in the NDA compared to any previous versions provided in the IND.

So, while the IND is an excellent starting material for the building of your NDA, I would recommend looking at your NDA as an independent document that contains all of the information that may be needed to approve your product - until such a time that submission software (including whatever FDA would be using) allows for inter-application links.
Original Message:
Sent: 26-Feb-2022 10:06
From: Andrea Chamblee
Subject: NDA Submission - Resubmit IND Information?

All that information does become "part" of the IND, but you can reference or link it in your NDA electronic submission.
See FDA Form 0356h and the 0356h Instructions. They are on this FDA forms page.
See especially the Form at #30 which is a checklist of 20 items to include in your NDA. It requires a " Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2).
Checklists on FDA marketing forms is my secret weapon for listing what I have to plan for in the years/decades leading up the filing.​
Good luck!

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States

Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

Hello Ken,

Not sure what you mean by "automatically" as the information has to be made accessible to the NDA reviewer. All of the relevant information contained in the reports is presented and discussed in the Module 2 summaries and links are provided to the original reports, either by including the reports in the NDA or by providing links to the reports in the IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

Thank you Andrea and Glen,

So if I understand correctly, the documents submitted to the IND can be resubmitted to the NDA, but the IND documents can alternatively be linked by reference to the NDA rather than resubmitting the documents.  And as you indicate Glen, the NDA Module 2 summaries will include all the relevant information from the IND.


------------------------------
Ken Rose
Painesville OH
United States
------------------------------

Original Message:
Sent: 28-Feb-2022 09:14
From: Glen Park
Subject: NDA Submission - Resubmit IND Information?

Hello Ken,

Not sure what you mean by "automatically" as the information has to be made accessible to the NDA reviewer. All of the relevant information contained in the reports is presented and discussed in the Module 2 summaries and links are provided to the original reports, either by including the reports in the NDA or by providing links to the reports in the IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Module 4 of NDA contains all the non-clinical studies from the initial IND to the current!
Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

Agree with the Anon's response "So, while the IND is an excellent starting material for the building of your NDA, I would recommend looking at your NDA as an independent document that contains all of the information that may be needed to approve your product - until such a time that submission software (including whatever FDA would be using) allows for inter-application links."

I have never heard of submitting an NDA with links to IND submitted documents! NDA/BLA is a stand alone document.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 25-Feb-2022 12:00
From: Anonymous Member
Subject: NDA Submission - Resubmit IND Information?

This message was posted by a user wishing to remain anonymous

Module 4 of NDA contains all the non-clinical studies from the initial IND to the current!
Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------

Cross Application Hyperlinking and Cross Application Referencing have been accepted by the FDA for close to, if not over, ten years now, if your eCTD software does not support this you are using the wrong software.

I would suggest using Cross Application Referencing to include the IND documents in the NDA as opposed to Cross Application Hyperlinking so that when the reviewer looks at the submission backbone they see all available documents instead of having to scan the M2 summaries for hyperlinks.

------------------------------
Stephen Sullivan
Assoc Director, Regulatory Operations
Melrose MA
United States
------------------------------

Original Message:
Sent: 25-Feb-2022 11:16
From: Ken Rose
Subject: NDA Submission - Resubmit IND Information?

Hello,

The FDA website states "The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." (New Drug Application (NDA))

Does this mean the information contained in the IND automatically transfers to the NDA and the Sponsor does not need to resubmit any of the previous information to the NDA?

Thanks,
Ken

------------------------------
Ken Rose
Painesville OH
United States
------------------------------