Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication.

Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA published a revised draft guidance in September 2023, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to focus on issues around the development and review of drugs or biological products. The draft guidance, entitled "Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products," is important because it provides Sponsors and applicants with tangible information and additional clarity concerning the Agency's expectations for these meetings.

Types of FDA Meetings

Five different types of formal meetings can occur between the FDA and Sponsors. Each type of meeting is subject to different procedures and processes. The FDA defines and outlines various details of each meeting type as follows:

Type A FDA Meetings

Type A FDA meetings are "necessary for an otherwise stalled product development program to proceed (a critical path meeting) or to address an important safety issue." Examples of these types of meetings include:

Dispute resolution meetings
Meetings to discuss clinical holds
Special protocol assessment meetings when requested after receiving the FDA's response to protocols submitted under the special protocol assessment procedures
Post-action meetings when requested within three months after receiving an FDA regulatory action other than approval

Before requesting a Type A meeting, the FDA advises Sponsors to contact the review division to discuss the appropriateness of the request.

Type B FDA Meetings

Type B FDA meetings are milestone meetings. According to the FDA's draft guidance, examples of a Type B meeting include:

Pre-IND meetings
Pre-emergency use authorization meetings
Certain end-of-phase one meetings (for subpart E or H or similar products)
End-of-phase 2/pre-phase three meetings
Pre-NDA/Pre-BLA meetings
Post-action meetings when requested within three months after receiving an FDA regulatory action other than approval.
Meetings regarding REMS or post-marketing requirements
Meetings to discuss the overall development program for products granted breakthrough therapy designation

Except in the most unusual circumstances, the FDA states it will honor most Type B meeting requests. The FDA intends to schedule all Type B meetings within 60 days of receiving the written meeting request and within 70 days of a Type B End-of-Phase 2 (EOP2) meeting request.

Type C FDA Meetings

Type C FDA meetings are a "catch-all" category and include any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. The FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.

When requesting a Type C meeting, Sponsors can request a written response to their questions rather than an in-person meeting, videoconference, or teleconference. A Sponsor may request a face-to-face meeting, but the FDA may decide that only a written response is necessary.

Type D FDA Meetings

Type D FDA meetings were added as a formal meeting type to allow for more timely feedback from the FDA to move a clinical program forward. Type D meetings focus on no more than two topics and across no more than three disciplines at the FDA. For example:

A follow-up question that raises a new issue after a formal meeting (i.e., more than just a clarifying question about an FDA response from a prior meeting)
A narrow issue on which the Sponsor is seeking Agency input with only a few (e.g., three to five questions total) associated questions
A general question about an innovative development approach that does not require extensive, detailed advice

The FDA notes that it will attempt to schedule all Type D meetings within 50 days of receiving the written meeting request. Sponsors are advised not to request multiple Type D meetings in quick succession. The Agency reserves the right to convert the meeting to a Type C meeting if the requirements for a Type D meeting are unmet.

INTERACT Meetings

Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings were added as a formal meeting type, specifically for novel products and/or development programs that present unique challenges early in development. These meetings must be held before a Type B Pre-IND Meeting or before filing an IND. The FDA notes that it will attempt to schedule all INTERACT meetings within 75 days of receiving the written meeting request. INTERACT meetings intend to assist with IND-enabling efforts with challenging programs. Sponsors should remain within the scope of questions appropriate for an INTERACT meeting. The FDA guidance provides the following examples of in-scope INTERACT topics:

Questions for novel products and development programs that present unique challenges in early development for all CDER and CBER products (i.e., questions for which there is no existing guidance or other information in writing the company could reference from the FDA)
Issues to address before a Pre-IND Meeting, for example:
Appropriate preclinical models or necessary toxicology studies
Chemistry, Manufacturing, and Controls (CMC) issues or testing strategies aimed to support first-in-human study
Design of proof-of-concept or other pilot safety/biodistribution studies to support administration in a first-in-human clinical trial
General recommendations about a future first-in-human trial for which the clinical population is novel, and there is no prior precedent or guidance
Approach for further development of an early-stage product with limited CMC; pharmacology/toxicology; and/or clinical data that were collected outside of a U.S. IND

Why Sponsors Should Request a Face-to-Face FDA Meeting

We advise Sponsors to request a face-to-face meeting because this is typically their first interaction with the FDA. The Sponsor is likely at a point in development where many decisions have yet to be made, so clear Agency feedback is critical. According to the 2023 guidance, "[s]ome meetings, particularly milestone meetings, can be valuable because of the broad discussion they generate and the opportunity for the division to ask about relevant matters." Without a face-to-face meeting, the opportunity for this discussion is lost.

The FDA suggests that only "core" attendees participate, if feasible, at face-to-face meetings. Face-to-face meetings will remain hybrid, with FDA's core members attending in person and having the opportunity to join virtually.

Since the COVID-19 pandemic, formal meetings with the FDA have frequently been granted as virtual face-to-face (or videoconference) meetings. As the FDA continues this practice, granting specific meetings as virtual only, the FDA suggests that "core" attendees have their cameras on. We find that this facilitates a better relationship with the Agency's attendees by reading body language and facial expressions and generating a familiarity with the FDA project manager and reviewers.

In our experience, written responses typically leave some room for interpretation. We have always used face-to-face interaction to improve upon and clarify the Agency's initial written response. We consider those live discussions worthwhile in gaining the certainty that Sponsors desire.

FDA Meeting Requests

Sponsors should proactively craft Meeting Request Letters that justify their need for a face-to-face meeting. The meeting request "should include enough information for the FDA to assess the potential utility of the meeting and to identify the FDA staff necessary to discuss proposed agenda items." The following information should be included in the meeting request:

Product name
Application number (if applicable)
Chemical name and structure
Proposed indication(s) or context of product development
Meeting type being requested
Brief statement of the purpose and objectives of the meeting
Proposed agenda
List of proposed questions, grouped by discipline
List all individuals who will be in attendance at the requested meeting (including name, title, and affiliations)
List of FDA staff, if known, or disciplines asked to participate in the requested meeting
Suggested dates and times for the meeting (must be within or beyond the appropriate time frame of the meeting type being requested)
Proposed format of the meeting (written response, face-to-face, etc.)
Approximate date the meeting package will be sent

After the meeting has been requested, the FDA will respond to the request per the timelines described in Table 1. At this point, the Agency will either grant or deny the Sponsor's request. If the meeting is dismissed, the notification will explain why the meeting was denied. Any denial made "will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items."

FDA Meeting Granted

If a meeting is granted, CBER or CDER will notify the Sponsor of its decision in writing according to the timelines provided in Table 1.

Rescheduling & Canceling Meetings

Sometimes, circumstances arise that require a meeting to be rescheduled or canceled; however, both the FDA and Sponsors should take reasonable steps to avoid this if at all possible. If it is unavoidable and a meeting must be rescheduled, it should be done as soon as possible after the original date. Sponsors only need to submit a new meeting request if the meeting has been canceled and they wish to reschedule.

In its draft guidance, the FDA provides examples of various situations that warrant either rescheduling or canceling a meeting. For more information, view the full draft guidance.

Contents & Submission of the Meeting Package

Preparation of the meeting package is critical to both the FDA and the Sponsor, as it allows the Agency to prepare adequately for the meeting and helps the Sponsor focus on describing its principal areas of interest. As such, the meeting package should contain information relevant to the meeting's discussion topics. It is also essential that the package is submitted to the Agency promptly to ensure the FDA has sufficient time to prepare and provide appropriate preliminary responses to meeting questions.

The revised 2023 FDA guidance stipulates that no more than ten total questions should be included in a meeting request. Sub-questions (i.e., Questions 1a, 1b, 1c) are counted as separate questions. Failure to comply with the limit on the number of questions may result in the meeting request being denied.

Timing of Submission

The meeting package should be submitted according to the timelines provided in Table 1.

Where to Send the Meeting Package

The meeting package should be sent to the appropriate review division within either CBER or CDER and should identify the meeting date, time, and subject. If a relevant application exists (e.g., IND, BLA, or NDA), an archival copy of the package should also be submitted via the electronic gateway.

The revised 2023 guidance notes that meeting requests and meeting packages can be submitted through the NextGen Portal (for CDER submissions only). Submissions through the portal do not require publishing and may be helpful for a tight timeline where eCTD publishing is impossible. This may be particularly useful for a Type B Pre-IND meeting request before an electronic IND has been opened.

Contents of the Meeting Package

The purpose of the meeting package is to provide a summary of the relevant product information and any supplementary information that may be needed to respond to issues raised by either the Sponsor or the FDA's review division.

The contents of the meeting package should support the intended meeting objectives and be organized according to the proposed meeting agenda. In general, the following information should be included in a meeting package:

Product name and application number (if applicable)
Chemical name and structure
Proposed indication
Dosage form, route of administration, and dosing regimen (frequency and duration)
List of all individuals who will be in attendance at the requested meeting (including name, title, and affiliations)
Background section, including:
- Brief history of the development program and the events leading up to the meeting
- Status of product development
Brief statement summarizing the meeting's purpose
Proposed agenda
List of the final questions for discussion
Data to support discussion organized by discipline and question

Pre-Meeting & Communication with Requesters

Prior to your meeting, the FDA will hold an internal meeting to discuss the meeting package and develop the preliminary responses to your questions. The Agency aims to communicate these preliminary responses to the Sponsor per the timelines provided in Table 1.

The Sponsor must notify the FDA within three calendar days of receipt of the preliminary responses to determine whether the meeting is still needed for Type B (End-of-Phase 2), Type C, Type D, and INTERACT meetings.

FDA Meeting Conduct

Meetings are chaired by an FDA staff member and begin with introductions and a agenda statement. Typically, Sponsors do not need to prepare presentations because the information to be discussed should be in the meeting package. However, if a Sponsor addressed plans to make a presentation, it should be addressed with the CBER or CDER point of contact before the meeting. The FDA also notes that the meeting length will not be increased to accommodate a presentation.

Before the meeting ends, meeting attendees should summarize the critical discussion points, agreements, clarifications, and action items. Generally, the Sponsor will be asked to present the summary. This is done to ensure a mutual understanding of meeting outcomes and action items. The FDA will then add or further clarify any essential items that were not covered in the summary so that these items can be included in the meeting minutes.

For more information on FDA meeting conduct and preparation, watch the video below for tips from Steve Jensen, Executive Vice President and Head of Regulatory Consulting.

Video: Getting Meetings Right: How to Prepare for Type B Meetings with the FDA

Documentation of FDA Meetings

The FDA's meeting minutes are the official record of the meeting. As such, the Agency intends to issue the official, finalized minutes within 30 days of the meeting.

Disputing Official Meeting Minutes

Per the updated 2023 guidance, Sponsors may submit follow-up opportunities or clarifying questions in a formal submission following a meeting with the Agency. A request should be submitted within 20 days of receipt of the official FDA meeting minutes. The FDA will respond within 20 calendar days of receipt of clarifying questions.

If there are still significant differences in the Sponsor's and FDA's understanding of the meeting minutes, the Sponsor should notify the Agency in writing concerning the specific disagreements. The FDA will consider the Sponsor's concerns, and if it is deemed that the minutes need to be altered, the changes will be documented in an addendum to the official minutes.

Get Help Preparing for Your Upcoming FDA Meeting

The revised 2023 draft guidance on formal meetings with the Agency contains of many important information for Sponsors and applicants to know and consider when preparing for a formal meeting with the FDA.

While this is simply a summary of the Agency's document, it is evident that there is a lot that goes into preparing for and attending an FDA meeting. As such, we know it can be a daunting task requiring substantial time and resources. That is why we are here to help. We have been working with the Agency for more than 40 years and have a proven track record of helping our clients achieve successful interactions with the FDA. We can do this for you, too. Contact us today to learn more about our services and how we can help with your FDA meeting.

**Table 1: Summary of FDA Meeting Management Procedural Goals**
FDA Meeting Type	FDA Response to Request	FDA Receipt of Meeting Package	FDA Preliminary Responses to Requester (if Applicable†)	Requester Response to FDA Preliminary Responses (if Applicable†)	FDA Scheduled Meeting Date (Days From Receipt of Request)	FDA Meeting Minutes to Requester (if Applicable†)
A	14 days	With meeting request	No later than two days before the meeting	-	Within 30 days	30 days after the meeting
B	21 days	No later than 30 days before the meeting	No later than two days before the meeting	-	Within 60 days	30 days after the meeting
B (EOP)*	14 days	No later than 50 days before the meeting**	No later than five days before the meeting	No later than three days after receipt of preliminary responses	Within 70 days	30 days after the meeting
C	21 days	No later than 47 days before the meeting***	No later than five days before the meeting	No later than three days after receipt of preliminary responses	Within 75 days	30 days after the meeting
D	14 days	With meeting request	No later than five days before the meeting	No later than three days after receipt of preliminary responses	Within 50 days	30 days after the meeting
INTERACT	21 days	With meeting request	No later than five days before the meeting	No later than three days after receipt of preliminary responses	Within 75 days	Preliminary responses annotated 30 days after the meeting

† Not applicable to written responses only.
* EOP = end of phase.
** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request, the requester’s meeting package will be due no sooner than six calendar days after FDA response time for issuing the letter granting the meeting (see Table 1 in section VI.B., Meeting Granted).
*** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the meeting package will be due no sooner than seven calendar days after FDA response time for issuing the letter granting the meeting (see Table 1 in section VI.B., Meeting Granted). For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint as the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the meeting request.

TAGS: General Regulatory FDA Meetings Regulatory Sciences