Proposed agenda of the meeting and attendees

Proposed agenda of the meeting

Follow the decision tree to understand how to approach this section of your Pre-IND MIP preparation based on your meeting logistics. (Each of the routes were designed based on FDA guidances and experiences from prior candidate submissions.)

Flowchart illustrating the Pre-IND meeting request potential outcomes. It starts with "Sponsor Requests Pre-IND Meeting with questions for the FDA." The process splits into two paths: "The FDA Agrees to the meeting" leading to "Teleconference Meeting," or "Written Response Only"; and "The FDA Denies the meeting" leading to "Address denial comments." — Pre-IND Meeting Request Potential Outcomes

In the event that the FDA denies your Pre-IND meeting request, you will need to address the gaps/concerns described in the meeting denial. There are a variety of reasons why a meeting can be denied, with the most common reason being that the applicant’s development plan is not yet ready for pre-IND feedback. Further development and data may need to be collected and summarized in an updated Pre-IND package before requesting a Pre-IND meeting a second time.

Option 1- Planning a Teleconference Meeting

	If you are requesting a teleconference for the Pre-IND meeting, it will be important to include the following (Note that a teleconference is not always granted. However, written feedback from the FDA will always be provided, whether a teleconference is requested/granted or not): A clear and concise list of the specific agenda items that will be covered during the meeting Here you can include a list of specific questions you have for the agency along with a brief statement about the background and purpose for each An estimated amount of time needed for each agenda item

Decorative icon of a group of people

If you are requesting a teleconference for the Pre-IND meeting, it will be important to include the following (Note that a teleconference is not always granted. However, written feedback from the FDA will always be provided, whether a teleconference is requested/granted or not):

A clear and concise list of the specific agenda items that will be covered during the meeting
1. Here you can include a list of specific questions you have for the agency along with a brief statement about the background and purpose for each
An estimated amount of time needed for each agenda item

The following is an example of the “Proposed Agenda Template”:

Proposed Agenda	Estimated Time (minutes)
Introductions and Objectives	X
(E.g., Agenda Item 1: Specific questions raised by sponsor)	XX
(E.g., Agenda Item 2: Meeting Summary)	XXX

This way you can ensure that the meeting is focused and productive!

Option 2- Written Response Only

	On the other hand, if you requested a WRO from the FDA, or if the FDA decides that a WRO is more appropriate, then no proposed agenda is needed. Even if you requested a teleconference, the Agency may determine that a written response to your questions would be the most appropriate means for providing feedback and advice. When it is determined that the meeting request can be appropriately addressed through a WRO, the FDA will respond with the date they intend on sending the written response to you, which is usually 60 days from the meeting request receipt date. The FDA will take requests for clarification to the responses they have provided after receipt of the WRO. If you believe a Pre-IND teleconference meeting is valuable and warranted, and your needs may not be addressed through a WRO, then you may provide a rationale in a follow-up correspondence explaining why a meeting is valuable and warranted. The FDA will convert, where possible, WRO to a teleconference meeting for requests that include novel approaches to development and/or where precedents are not well established. You may refer to the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027 or any latest PDUFA guidance for more information.

Decorative icon showing communication methods

On the other hand, if you requested a WRO from the FDA, or if the FDA decides that a WRO is more appropriate, then no proposed agenda is needed. Even if you requested a teleconference, the Agency may determine that a written response to your questions would be the most appropriate means for providing feedback and advice.

When it is determined that the meeting request can be appropriately addressed through a WRO, the FDA will respond with the date they intend on sending the written response to you, which is usually 60 days from the meeting request receipt date.

The FDA will take requests for clarification to the responses they have provided after receipt of the WRO. If you believe a Pre-IND teleconference meeting is valuable and warranted, and your needs may not be addressed through a WRO, then you may provide a rationale in a follow-up correspondence explaining why a meeting is valuable and warranted. The FDA will convert, where possible, WRO to a teleconference meeting for requests that include novel approaches to development and/or where precedents are not well established.

You may refer to the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027 or any latest PDUFA guidance for more information.

The FDA may deny the request for a teleconference meeting and choose the WRO or deny the request altogether for several reasons (and the FDA’s letter will include an explanation of the reason for any denial). For instance, a meeting can be denied because the application is at too premature of a stage in development, or the request/MIP does not provide an adequate basis for the meeting discussion.
The FDA may also choose the WRO option due to resource issues. However, this option is not preferred as it limits the opportunity for discussion or clarification, so denials are usually based on a substantive reason, e.g., not merely on the absence of a minor element of the meeting request or meeting package items. [7]

Attendees

In this section you will be providing the FDA with a list of individuals from your organization who will attend the meeting. List their names along with their respective disciplines including affiliations and titles. Usually, the FDA provides preliminary advice a few days prior to the meeting date, after which the team should triage and decide the questions, they intend on bringing up at the actual meeting. To improve productivity, we recommend that you first short-list the questions you want to focus on and then match subject matter experts (SMEs) with disciplines based on those question(s) to attend the meeting.

The FDA also encourages that you consider including patient representatives in the meeting (either the patients themselves and/or their family members/caregivers) where topics would benefit from

By doing so you will not only provide the FDA with an overview of whom to expect at the meeting but also ensure that all key stakeholders are included for a productive discussion.

The following is an example of the “List of Attendees Template”

Name of Sponsor’s Attendee/Investigator	Affiliation / Collaborative Institute	Role/Contribution
Attendee 1	X	CMC/Pharmacology/Toxicology/Clinical/Biostatistics/ Principal Investigator etc.
Attendee 2	XX	CMC/Pharmacology/Toxicology/Clinical/Biostatistics/ Principal Investigator etc.
Attendee 3	XXX	CMC/Pharmacology/Toxicology/Clinical/Biostatistics/ Principal Investigator etc.

Documentation Index

Proposed agenda of the meeting and attendees