USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

Sharan Murugan
18 minutes ago
7 min read

Formal meetings between the U.S. Food and Drug Administration (FDA) and sponsors or applicants can play an important role at critical points in drug and biological product development. These interactions provide an opportunity for sponsors to obtain regulatory advice, discuss development challenges, clarify specific issues, and support efficient planning of development and regulatory submissions.

The FDA’s August 2026 guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, provides standardized recommendations for requesting, preparing, scheduling, conducting, and documenting formal meetings between FDA and sponsors or applicants of products regulated by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products.

The guidance describes six formal meeting types, four meeting formats, meeting request requirements, meeting package expectations, FDA response timelines, preliminary responses, meeting conduct, and final meeting minutes.

What Does the Guidance Cover?

The guidance applies to formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products regulated by CDER and CBER.

It does not apply to abbreviated new drug applications, applications for biosimilar products, including interchangeable biosimilars, or submissions for medical devices.

A formal meeting may be conducted through different formats, including hybrid in-person face-to-face meetings, virtual face-to-face meetings, teleconferences, or written response only (WRO). The guidance is intended to establish consistent meeting management practices so that meetings are appropriately requested, prepared, scheduled, conducted, and documented.

Six Types of Formal FDA Meetings

The guidance identifies six types of formal meetings under PDUFA. Selecting the appropriate meeting type is important because each type has a specific purpose and associated procedural timelines.

Meeting Type	Primary Purpose
Type A	Necessary for an otherwise stalled development program or to address an important safety issue
Type B	Includes pre-IND, pre-EUA, pre-NDA/pre-sNDA, pre-BLA/pre-sBLA and certain post-action or development meetings
Type B (EOP)	Certain end-of-phase 1 and end-of-phase 2 meetings
Type C	Development and review meetings that do not fall into the other defined categories
Type D	Focused discussion of a narrow set of issues, generally no more than two focused topics
INTERACT	Early regulatory engagement for novel products and development programs presenting unique challenges

Four Meeting Formats

Sponsors or applicants can request different meeting formats depending on the purpose and circumstances of the interaction.

The guidance describes four formats: hybrid in-person face-to-face, virtual face-to-face video conference, teleconference, and written response only (WRO).

In a hybrid in-person meeting, core FDA and requester participants generally participate in person while non-core participants may join virtually. Virtual face-to-face meetings are conducted through a virtual meeting platform, while teleconferences use an audio-only connection. Under WRO, FDA provides written responses instead of conducting a live meeting.

For certain Type B, Type C, Type D, and INTERACT requests, FDA may determine that a WRO is the appropriate format even when the requester initially asks for another format.

Planning the Meeting Request

Before requesting a meeting, sponsors should make use of publicly available FDA information, including guidances, web pages, portals, and databases. The guidance also recommends anticipating future regulatory needs and addressing related development issues in as few meetings as practical.

In general, there should be no more than 10 total questions, including subquestions, for FDA consideration in a meeting request. Questions should be sufficiently focused to allow meaningful discussion within the allotted meeting time.

The meeting request should provide FDA with enough information to understand the purpose and utility of the meeting and identify the appropriate FDA staff.

Key information includes:

Proposed meeting format
Planned meeting package submission date
Meeting purpose and background
Summary of relevant studies, trials, or data
Proposed agenda
Requester attendees and affiliations
Requested FDA attendees or disciplines
Application number, if available
Drug or biological product name
Proposed regulatory pathway
Proposed indication or development context
Requested meeting type
Specific objectives and expected outcomes
Pediatric study plans, where applicable
Human factors engineering plan, where applicable
Combination product information, where applicable
Proposed meeting dates and times
Precise questions grouped by FDA discipline

The guidance emphasizes that the questions are one of the most critical elements of the request because they help FDA determine the expertise required, assess whether the questions can reasonably be addressed, and focus the discussion.

FDA Meeting Response and Scheduling Timelines

The guidance establishes procedural goals for FDA responses and meeting scheduling under the PDUFA framework.

Meeting Type	FDA Response to Request	FDA Meeting Scheduling / WRO
Type A	14 days	30 days
Type B	21 days	60 days
Type B (EOP)	14 days	70 days
Type C	21 days	75 days
Type D	14 days	50 days
INTERACT	21 days	75 days

These timelines are calendar-day goals from receipt of the meeting request. The guidance also provides specific timelines for submission of the meeting package and FDA preliminary responses.

Meeting Package: The Foundation for a Productive Discussion

Premeeting preparation is critical because the meeting package provides FDA with the information needed to prepare for the discussion.

The timing of the meeting package depends on the meeting type.

Meeting Type	Meeting Package Timing
Type A	At the time of the meeting request
Type B	No later than 30 days before the scheduled meeting or WRO response
Type B (EOP)	No later than 50 days before the scheduled meeting or WRO response
Type C	No later than 47 days before the scheduled meeting or WRO response
Type D	At the time of the meeting request
INTERACT	At the time of the meeting request

For certain Type C meetings involving early consultation on a new surrogate endpoint, the package is also due with the meeting request.

The meeting package should be organized according to the proposed agenda and should be sequentially paginated, include a table of contents with appropriate electronic linkage, indices, appendices, and cross-references.

The package should generally include the meeting purpose, background and development history, current development status, proposed agenda, final questions, and summarized data supporting the discussion. The guidance emphasizes that detailed protocols, full study reports, or extensive detailed data are generally not appropriate for meeting packages; relevant study and clinical trial results should instead be summarized with sufficient quantitative information to support the discussion.

Preliminary FDA Responses Before the Meeting

For Type B (EOP), Type C, Type D, and INTERACT meetings, FDA intends to provide preliminary responses no later than 5 calendar days before the meeting.

The requester then has 3 calendar days following receipt of those responses to notify FDA whether the meeting is still needed. If the meeting remains necessary, the requester should provide a revised agenda identifying questions that have been resolved and those that require further discussion.

For Type A and Type B meetings other than Type B (EOP), FDA intends to provide preliminary responses no later than 2 calendar days before the meeting.

Preliminary responses are not intended to generate new information or new questions. If a requester submits new data or a revised or new proposal, FDA may not be able to provide comments on that information, and a new meeting request may be necessary.

Rescheduling and Cancellation

The guidance also establishes expectations for rescheduling and canceling formal meetings.

If a meeting needs to be rescheduled, it should be rescheduled as soon as possible after the original date, and a new meeting request should not be submitted. However, if a meeting is canceled, a subsequent request to schedule the meeting will be treated as a new request and will receive a new set of applicable time frames.

A meeting may need to be rescheduled when the meeting package is delayed, additional information is needed, the package is too voluminous for adequate review, new questions or data are submitted, or essential FDA or requester attendees become unavailable.

A meeting may also be canceled if the meeting package is not received within the required timeframe or is grossly inadequate. If FDA agrees that preliminary responses adequately address the requester’s needs, the meeting may also be canceled, with the preliminary responses becoming the final responses and official record.

Conducting the FDA Meeting

FDA meetings are chaired by an FDA staff member and begin with introductions and an overview of the agenda. FDA policy prohibits audio or visual recording of discussions during meetings.

Presentations by requesters are generally unnecessary because the relevant information should already be contained in the meeting package. If a presentation is planned, the materials should be provided in advance and the presentation should remain brief so that sufficient time is available for discussion.

At the end of the meeting, important discussion points, agreements, clarifications, and action items should be summarized to ensure mutual understanding between FDA and the requester.

Meeting Minutes and Follow-Up

FDA meeting minutes are the official records of formal meetings. The finalized minutes are issued to the requester within 30 calendar days after the meeting.

The minutes document important agreements, disagreements, issues requiring further discussion, and action items. They are not intended to be a transcript of the meeting.

If the requester identifies a significant difference between its understanding and the FDA’s final meeting minutes, the requester should contact the FDA project manager. If differences remain, the requester can submit a description of the specific disagreement to the application or, when there is no application, to the division director with a copy to the FDA project manager.

For clarification of FDA feedback, requesters may submit follow-up clarifying questions within 20 calendar days after receiving the meeting minutes or WRO. These questions should be limited to clarification of advice already provided and should not introduce new issues or proposals. FDA will issue a written response within 20 calendar days for questions that meet the clarification criteria.

What This Means for Regulatory and Clinical Teams

The August 2026 guidance provides a structured framework for managing formal FDA interactions throughout drug and biological product development.

For Regulatory Affairs and Clinical teams, effective meeting planning begins with selecting the appropriate meeting type, defining focused questions, identifying the necessary FDA disciplines, preparing a concise and well-organized meeting package, and managing the procedural timelines.

The guidance also makes clear that the quality of the interaction depends heavily on preparation. A focused meeting request and a meeting package that directly supports the proposed questions can help FDA prepare effectively and enable a more productive discussion.

From meeting request through final minutes and follow-up clarification, formal FDA meetings should therefore be managed as an integrated regulatory process rather than as a single meeting event.