A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can go about conducting efficient, consistent, timely and effective meetings.
Meeting Types
FDA describes four types of meetings. Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important safety issue. Before submitting a Type A meeting request, requesters should contact the review division or office to discuss the appropriateness of the request.
Type B meetings include, but are not limited to: Pre-investigational new drug application (pre-IND) meetings; Pre-emergency use authorization meetings; and Pre-new drug application (pre-NDA)/pre-biologics license application (pre-BLA) meetings (21 CFR 312.47).
Type B (EOP) meetings are as follows: Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar products) and end-of-phase 2 or pre-phase 3 meetings (21 CFR 312.47).
A Type C meeting is any meeting other than a Type A, Type B, or Type B (EOP) meeting regarding the development and review of a product, including meetings to facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use.
Meeting Requests
According to the FDA’s guidance, before seeking a meeting, requesters should use the extensive sources of product development information that are publically available. To disseminate a broad range of information in a manner that can be easily and rapidly accessed by interested parties, the FDA develops and maintains web pages, portals, and databases, and participates in interactive media as a means of providing advice on scientific and regulatory issues that fall outside of established guidance, policy, and procedures.
To promote efficient meeting management, requesters should try to anticipate future needs and, to the extent practical, combine product development issues into the fewest possible meetings. When a meeting is needed, a written request must be submitted to the FDA via the respective center’s document room (paper submissions) or via the electronic gateway, as appropriate. Requests should be addressed to the appropriate review division or office and, if previously assigned, submitted to the application.
The meeting request should include the following information:
- The application number (if previously assigned).
- The product name.
- The chemical name, established name, and/or structure.
- The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2)).
- The proposed indication(s) or context of product development.
- The meeting type being requested.
- Pediatric study plans, if applicable.
- Human factors engineering plan, if applicable.
- Combination product information (e.g., constituent parts, including details of the device constituent part, intended packaging, planned human factors studies), if applicable.
- Suggested dates and times (e.g., morning or afternoon) for the meeting that are consistent with the appropriate scheduling time frame for the meeting type being requested. Dates and times when the requester is not available should also be included.
- A list of proposed questions, grouped by FDA discipline. For each question there should be a brief explanation of the context and purpose of the question.
Request Granted or Denied
If a meeting request is denied, the FDA will notify the requester in writing. The FDA’s letter will include an explanation of the reason for the denial. Denials will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items. For example, a meeting can be denied because it is premature for the stage of product development or because the meeting package does not provide an adequate basis for the meeting discussion. Thus, the FDA will generally deny requests for Type A meetings and Type C meetings to discuss the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval that do not include an adequate meeting package in the original request. The FDA may also deny requests for meetings that do not have substantive required elements. A subsequent request to schedule the meeting will be considered as a new request.
If a meeting request is granted, the FDA will notify the requester in writing. For face-to-face and teleconference/videoconference meetings, the FDA’s letter will include the date, time, conferencing arrangements and/or location of the meeting, as well as expected FDA participants. For face-to-face and teleconference/videoconference meetings, the FDA will schedule the meeting on the next available date at which all expected FDA staff are available to attend; however, the meeting should be scheduled consistent with the type of meeting requested. If the requested date for any meeting type is greater than the specified time frame, the meeting date should be within 14 calendar days of the requested date.