Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products - September 2023
The FDA recently released a new, revised guidance, entitled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” This guidance includes two meeting types: the Type D meeting and INTERACT Meeting that were previously mentioned in the PDUFA VII Commitment Letter. This blog post summarizes and breaks down the key points of the new guidance, including the updates and changes made regarding Type D and INTERACT meetings.
This guidance states that it: “provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter referred to as products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).”
FDA issued the revised draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products in September of 2023. This updated version replaces the draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products issued in December 2017.
This draft guidance:
• Outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products,
• Describes the different meeting types, formats, and timelines associated with those requests, and,
• Provides industry with the information necessary to have a complete meeting request and background package to help facilitate the meeting to gain useful feedback for product development.
This 24-page guidance supersedes the original guidance issued in December of 2017. While information is included on Type A, B, B (EOP), and C meetings, the tangible updates have been primarily made to Type D and INTERACT meeting formats.
• Provides recommendations to industry on formal meetings with the FDA.
• Discusses the principles of good meeting management practices.
• Describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.
• Reiterates the intention of each type of meeting with FDA.
The draft guidance provides examples to help guide stakeholders on selecting and requesting the proper meeting type for a given scenario, including Type D and INTERACT meetings.
• Type D meetings are meetings for a narrow set of issues, involving a few disciplines or as a follow up from a former meeting. It requires a combined meeting request and briefing book. The timeline from request to meeting is 60 days.
o Examples or scenarios for a Type D meeting request include:
• A sponsor has a specific question about an aspect of a complex or innovative trial design (e.g., innovative pediatric design approach).
• A sponsor has a specific question about presenting data following a pre-BLA/NDA meeting.
• A sponsor has a specific follow-up question about a new idea stemming from a Type C meeting.
• INTERACT meetings were formerly in place for biologics / gene and cell therapy products, but the scope has now been widened to all products. INTERACT meetings are intended for novel products and development programs that present unique challenges in early development (i.e., before filing of an IND or before having a pre-IND meeting). The issues typically relate to IND requirements.
o Examples or scenarios for an INTERACT meeting request include:
• 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 FDA).
• Issues that a sponsor needs to address before a pre-IND meeting.
As a reminder, requesters should strive to review necessary guidances and other publicly available information before seeking out a meeting with the FDA. To promote an efficient meeting, requesters should anticipate future needs wherever possible and address product development issues upfront to avoid costly delays or multiple meetings.
All meeting requests to the FDA should include adequate preparation of questions to ensure a streamlined meeting. The meeting request should also 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 (i.e., Type A, Type B, Type B (EOP), Type C, Type D, or INTERACT),
• 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 (see 296 Table 2 in section VI.B., Meeting Granted). Dates and times when the requester is not available should also be included, and,
• 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.
Conclusion & Final Thoughts
Meetings with the FDA require adequate planning and adept guidance. These updates to Type D and INTERACT meeting formats are essential to the development of new drug applications.
Are you beginning the process of meeting with the FDA? Bracken is here to help. We developed a calculator to provide you with a clearer understanding of the timing and steps required to get an FDA meeting granted on the timeline that fits your program, as well as a robust checklist to keep you on track.