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This message was posted by a user wishing to remain anonymous

Hi, the PreIND meeting Briefing Package is usually structured as questions followed by supporting information by functions such as Quality, Nonclinical and Clinical. Since there is no published template by the FDA, I wonder if others have experience in structuring the briefing package differently? e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas.

This message was posted by a user wishing to remain anonymous

"as questions followed by supporting information"

"e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas."

Above both appear to be same? Anyhow, FDA will not reject if you structure differently!

Original Message:
Sent: 04-Oct-2023 14:58
From: Anonymous Member
Subject: PIND Meeting Briefing Package format

This message was posted by a user wishing to remain anonymous

Hi, the PreIND meeting Briefing Package is usually structured as questions followed by supporting information by functions such as Quality, Nonclinical and Clinical. Since there is no published template by the FDA, I wonder if others have experience in structuring the briefing package differently? e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas.

Hi Anon,

The "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry" (https://www.fda.gov/media/172311/download) does suggest a format.  In Section C Meeting Package Content, there is the comment "Meeting packages generally should include the following information, "preferably in the order listed below".  It then goes on to list the content.  I have generally followed the guidance document and created a template based on it.

Regards,

Ken

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Ken Rose
Painesville OH
United States
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Original Message:
Sent: 04-Oct-2023 14:58
From: Anonymous Member
Subject: PIND Meeting Briefing Package format

This message was posted by a user wishing to remain anonymous

Hi, the PreIND meeting Briefing Package is usually structured as questions followed by supporting information by functions such as Quality, Nonclinical and Clinical. Since there is no published template by the FDA, I wonder if others have experience in structuring the briefing package differently? e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas.

I have generally followed Ken's approach in terms of document strucutre.

In terms of how much to put in the "sponsor position" after a question vs. separate section "supporting information" I think that is a question of preference. I generally like to present the arguments tying all supportive data together in the Sponsor position over 1-3 pages, depending on the complexity. Any data I reference in the Sponsor position (e.g., nonclinical or clinical study) is then placed in the "supporting information" section so that FDA doesn't have to dig through our IND to find the content but has it readily accessible the briefing book.  

Good luck!

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Anna Sedello, PhD, RAC-Drugs
Executive Director of Regulatory Affairs
Palo Alto CA
United States
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Original Message:
Sent: 05-Oct-2023 10:08
From: Ken Rose
Subject: PIND Meeting Briefing Package format

Hi Anon,

The "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry" (https://www.fda.gov/media/172311/download) does suggest a format.  In Section C Meeting Package Content, there is the comment "Meeting packages generally should include the following information, "preferably in the order listed below".  It then goes on to list the content.  I have generally followed the guidance document and created a template based on it.

Regards,

Ken

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

Original Message:
Sent: 04-Oct-2023 14:58
From: Anonymous Member
Subject: PIND Meeting Briefing Package format

This message was posted by a user wishing to remain anonymous

Hi, the PreIND meeting Briefing Package is usually structured as questions followed by supporting information by functions such as Quality, Nonclinical and Clinical. Since there is no published template by the FDA, I wonder if others have experience in structuring the briefing package differently? e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas.

Hi Anon,

If you think the multidisciplinary nature of some of your questions could create some confusion, try putting them in a table by discipline. Even if this table is for your own use and not submitted, it may help clarify the best way to organize the questions. It may also point out where information for a given discipline is not as thorough as for the other disciplines involved in the question. 

Best of luck,

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
------------------------------

Original Message:
Sent: 04-Oct-2023 14:58
From: Anonymous Member
Subject: PIND Meeting Briefing Package format

This message was posted by a user wishing to remain anonymous

Hi, the PreIND meeting Briefing Package is usually structured as questions followed by supporting information by functions such as Quality, Nonclinical and Clinical. Since there is no published template by the FDA, I wonder if others have experience in structuring the briefing package differently? e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas.

I agree with Ken Rose that the FDA prefers the Pre-IND meeting format outlined in the Guidance (https://www.fda.gov/media/172311/download). I suggest that you review our web page which may help with any other Pre-IND meetings in other Offices https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-pre-ind-meetings.  You should list your final questions for discussion grouped by discipline such as Quality (CMC), Nonclinical (Pharmacology & Toxicology), Clinical, Biostatistics, and more recently I've seen specific questions for Bioinformatics, Regulatory /  Administrative with a brief summary for each question. This not only helps us better organize our regulatory documents but it also helps each discipline reviewer to better organize and present their review during the internal meetings. For questions that may require input from different discipline reviewers you may just cross reference the supporting information in other sections of the Pre-IND meeting package if needed.  I've seen reviewers adding comments for their discipline for questions originally addressed to a different review team and this is perfectly fine. I hope this helps. 

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
------------------------------

Original Message:
Sent: 04-Oct-2023 14:58
From: Anonymous Member
Subject: PIND Meeting Briefing Package format

This message was posted by a user wishing to remain anonymous

Hi, the PreIND meeting Briefing Package is usually structured as questions followed by supporting information by functions such as Quality, Nonclinical and Clinical. Since there is no published template by the FDA, I wonder if others have experience in structuring the briefing package differently? e.g. writing the supporting information supporting EACH question which could be multidisciplinary areas.