Regulatory Open Forum

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

https://www.fda.gov:80/FDAgov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Hi, Sabrina -

DMFs are only reviewed by FDA when referred to in an application - the DMF holder will not receive comments on it until the DMF is used as part of the review of an IND, NDA, BLA, etc. The FDA will then look at the totality of the information (application + DMF) to determine if there is sufficient information for clearance/approval.  The important thing as the application sponsor is to be certain that the DMF contains the information you need - many places will allow you to review their DMF on site, even though very few will provide a copy.  Note that the comments on the DMF will go back to the DMF holder, not the application holder, so you need good communication between the two entities. 

There are some very good guidance documents on the FDA website on how to put a DMF together, and in my experience, FDA has been very responsive when I have reached out to the help e-mail. 

Best of luck!

Cathy

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Thank you Catherine! We did send an email to the FDA and they recently responded that there is not a similar process as what is used for DMFs submitted per GDUFA.
I agree that the FDA will only do the technical review of the DMF when reviewing the BLA/NDA etc...however for generic submissions a Completeness assessment is performed prior to the technical review then the FDA becomes available for reference on FDA's website.

Thanks!!

Sabrina

​Hi, Sabrina -

DMFs are only reviewed by FDA when referred to in an application - the DMF holder will not receive comments on it until the DMF is used as part of the review of an IND, NDA, BLA, etc. The FDA will then look at the totality of the information (application + DMF) to determine if there is sufficient information for clearance/approval.  The important thing as the application sponsor is to be certain that the DMF contains the information you need - many places will allow you to review their DMF on site, even though very few will provide a copy.  Note that the comments on the DMF will go back to the DMF holder, not the application holder, so you need good communication between the two entities.

There are some very good guidance documents on the FDA website on how to put a DMF together, and in my experience, FDA has been very responsive when I have reached out to the help e-mail.

Best of luck!

Cathy

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Thank you Catherine! We did send an email to the FDA and they recently responded that there is not a similar process as what is used for DMFs submitted per GDUFA.
I agree that the FDA will only do the technical review of the DMF when reviewing the BLA/NDA etc...however for generic submissions a Completeness assessment is performed prior to the technical review then the FDA becomes available for reference on FDA's website.

Thanks!!

Sabrina

​Hi, Sabrina -

DMFs are only reviewed by FDA when referred to in an application - the DMF holder will not receive comments on it until the DMF is used as part of the review of an IND, NDA, BLA, etc. The FDA will then look at the totality of the information (application + DMF) to determine if there is sufficient information for clearance/approval.  The important thing as the application sponsor is to be certain that the DMF contains the information you need - many places will allow you to review their DMF on site, even though very few will provide a copy.  Note that the comments on the DMF will go back to the DMF holder, not the application holder, so you need good communication between the two entities.

There are some very good guidance documents on the FDA website on how to put a DMF together, and in my experience, FDA has been very responsive when I have reached out to the help e-mail.

Best of luck!

Cathy

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Thank you Catherine! We did send an email to the FDA and they recently responded that there is not a similar process as what is used for DMFs submitted per GDUFA.
I agree that the FDA will only do the technical review of the DMF when reviewing the BLA/NDA etc...however for generic submissions a Completeness assessment is performed prior to the technical review then the FDA becomes available for reference on FDA's website.

Thanks!!

Sabrina

​Hi, Sabrina -

DMFs are only reviewed by FDA when referred to in an application - the DMF holder will not receive comments on it until the DMF is used as part of the review of an IND, NDA, BLA, etc. The FDA will then look at the totality of the information (application + DMF) to determine if there is sufficient information for clearance/approval.  The important thing as the application sponsor is to be certain that the DMF contains the information you need - many places will allow you to review their DMF on site, even though very few will provide a copy.  Note that the comments on the DMF will go back to the DMF holder, not the application holder, so you need good communication between the two entities.

There are some very good guidance documents on the FDA website on how to put a DMF together, and in my experience, FDA has been very responsive when I have reached out to the help e-mail.

Best of luck!

Cathy

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Thank you Catherine! We did send an email to the FDA and they recently responded that there is not a similar process as what is used for DMFs submitted per GDUFA.
I agree that the FDA will only do the technical review of the DMF when reviewing the BLA/NDA etc...however for generic submissions a Completeness assessment is performed prior to the technical review then the FDA becomes available for reference on FDA's website.

Thanks!!

Sabrina

​Hi, Sabrina -

DMFs are only reviewed by FDA when referred to in an application - the DMF holder will not receive comments on it until the DMF is used as part of the review of an IND, NDA, BLA, etc. The FDA will then look at the totality of the information (application + DMF) to determine if there is sufficient information for clearance/approval.  The important thing as the application sponsor is to be certain that the DMF contains the information you need - many places will allow you to review their DMF on site, even though very few will provide a copy.  Note that the comments on the DMF will go back to the DMF holder, not the application holder, so you need good communication between the two entities.

There are some very good guidance documents on the FDA website on how to put a DMF together, and in my experience, FDA has been very responsive when I have reached out to the help e-mail.

Best of luck!

Cathy

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina

​Good morning everyone,

When filing a DMF that will be used to support an ANDA, the FDA follows the completeness assessment guideline/checklist (per GDUFA). Does anyone know if there is a similar process when filing a DMF in support of a NDA or BLA (PDUFA)? I am trying to understand what could potentially cause a RTF for the NDA/BLA as it pertains to the DMF. I did not find any particular requirements on FDA's website but wanted to pick everyone's brains on the forum.

Thanks,

Sabrina