#1: Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products

FDA Draft Guidance Regarding Formal Meetings Between FDA & Sponsors or Applicants

By Kristen Booth

On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and sponsors.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  The draft guidance, entitled “Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products,” is important because it provides sponsors and applicants with tangible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 Meetings

There are three different types of formal meetings that can occur between the FDA and sponsors.  Each type of meeting is subject to different procedures and processes.  FDA defines and outlines various details of each meeting type, as follows:

Type A Meetings

Type A meetings are meetings that 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:

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

Before a request is submitted for a Type A meeting, FDA advises sponsors to contact the review division to discuss the appropriateness of the request.  FDA also notes that it should schedule Type A meetings to occur within 30 days of receiving a written meeting request.

Type B Meetings

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  According to FDA’s draft guidance, examples of a Type B meeting include:

  1. Pre-IND Meetings
  2. Pre-emergency use authorization meetings
  3. Certain end-of-phase 1 meetings (for subpart E or H or similar products)
  4. End-of-phase 2/pre-phase 3 meetings
  5. Pre-NDA/pre-BLA meetings
  6. Post-action meetings when requested within three months after receiving an FDA regulatory action other than approval.
  7. Meetings regarding REMS or postmarketing requirements
  8. Meetings to discuss the overall development program for products granted breakthrough therapy designation

Except in the most unusual circumstances, FDA states that it will honor most Type B meeting requests.  The FDA intends to schedule all Type B meetings to occur within 60 days of receiving the written meeting request.

Type C Meetings

Type C meetings are basically a “catch all” category and includes any meeting concerning the development and review of a product that does not fall within the scope of Types A or B.  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.  In some cases, a sponsor may request a face-to-face meeting, but FDA may decide that only a written response is necessary.

Meeting Requests

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:

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

After the meeting has been requested, FDA will respond to Type A meeting requests within 14 days, and Type B and C meeting requests within 21 days.  At this point, the Agency will either grant or deny the sponsor’s request.  If the meeting is denied, the notification will include an explanation as to why the meeting was denied.  Any denial that is 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.”

If a meeting is granted, CBER or CDER will notify the sponsor of its decision and the meeting will be scheduled by determining the meeting type, date, time, length, place, and expected FDA participants

Rescheduling & Canceling Meetings

Sometimes, circumstances arise that require a meeting to be rescheduled or cancelled, however both 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.  Furthermore, sponsors only need to submit a new meeting request if the meeting has been cancelled and they then wish to reschedule.

In its draft guidance, FDA provides examples of various situations which would warrant either the rescheduling or canceling of a meeting.  For more info, 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 that is relevant to the meeting’s discussion topics.  It is also important that the package is submitted to the Agency in a timely manner, ensuring that FDA has sufficient time to prepare and provide appropriate preliminary responses to meeting questions.

Timing of Submission

The meeting package should be submitted according to the following timelines:

  • Type A meeting – at the same time as the meeting request
  • Type B & C meetings – at least one month prior to the formal meeting

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 date, time, and subject of the meeting.  If a relevant application exists (e.g. IND, BLA, or NDA), an archival copy of the package should also be submitted, which FDA recommends being submitted electronically.  If no established application exists (e.g. Pre-IND Meetings) the sponsor should contact the reviewing division for instructions.

Number of Copies of the Meeting Package to Submit

The number of copies of the meeting package will vary from meeting to meeting.  “The responsible point of contact in the review division will advise on the number of copies needed for the meeting attendees.”

Contents of the Meeting Package

The purpose of the meeting package is to provide a summary of the relevant product information as well as any supplementary information that may be needed to respond to issues raised by the either the sponsor or the review division.

The contents of the meeting package should support the intended meeting objectives and should 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

Premeeting & Communication with Requesters

Prior to your meeting, FDA will hold an internal meeting to discuss the meeting package and develop the preliminary responses to your questions.  The Agency’s goal is to communicate these preliminary responses to the sponsor at least two days before the scheduled meeting date.  FDA’s preliminary responses are not intended to generate the submission of a new meeting agenda or new questions.

Meeting Conduct

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

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

Documentation of 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

If additional clarification is needed regarding the meeting minutes that are issued by the FDA, the sponsor should contact the assigned FDA point of contact for advice.  If there are still significant differences in the sponsor’s and the FDA’s understanding of the meeting minutes, the sponsor should notify the Agency in writing concerning the specific disagreements.  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.

As you can see, this draft guidance contains a ton of 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 amounts of time and resources.  That is why we are here to help.  We have been working with the Agency for more than 33 years and have a proven track record of helping our clients achieve successful interactions with the FDA.  We can do this for you too.  To learn more about our services and how we can help with your FDA meeting, contact us today.
Written by Kristen Booth, Marketing Associate at The Weinberg Group, the world’s leading food and drug consulting firm.  If you have any questions or thoughts on this blog post or others, please contact us today.