Post-PDUFA VII Updates: FDA Meetings Public Workshop & Lessons Learned

This article serves as an update on FDA formal meeting management since PDUFA VII went into effect in 2023, with insight from an FDA public workshop in July 2024 on meeting management and performance under PDUFA VII.
PDUFA VII and How FDA Formal Meetings Changed
The current iteration of the Prescription Drug User Fee act, PDUFA VII, went into effect at the beginning of 2023 and incorporated a number of enhancements. Specific to FDA formal meetings, PDUVA VII introduced a new meeting type (Type D), performance goals for INTERACT meetings, and additional details on formal meeting-related procedures incorporated in FDA’s most recently released draft Formal Meeting guidance (Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products | FDA).
The FDA’s PDUFA VII commitment letter outlines several additions and enhancements for Sponsors pursuing formal FDA meetings and related procedures. New meeting information was introduced, as follows:
- New Meeting Format (Type D): Type D meetings are restricted to a narrow set of issues which Sponsors needing timely feedback to move their program forward. The benefit of this format is the narrow focus streamlines more rapid FDA feedback than a Type C meeting at 25 calendar days earlier. For a meeting request to be eligible for Type D, the meeting scope cannot require more than two FDA disciplines to participate, and cannot ask more than five total questions.
- New FDA Performance Goals (INTERACT): Initial Targeted Engagement for Regulatory Advice (INTERACT) meetings are intended for novel questions and unique challenges in early development (prior to IND filing). While INTERACT was established before PDUFA VII, FDA performance goals were introduced with the FDA responding to sponsor INTERACT requests within 21 days of the request and scheduling meetings within 75 days.
For further detail on the above items and other related materials discussed in PDUFA VII, please reference the Updates to FDA Meetings under PDUFA VII.
July 2024 FDA Public Workshop: Best Practices for Meeting Management Under PDUFA VII
In July 2024, the FDA held a public workshop on best practices with formal meeting management with the Agency under PDUFA VII. The FDA organized this workshop in fulfillment of their commitment under PDUFA VII to host external training for industry awareness on meeting best practices outlined in guidance.
Topics covered in this workshop included the following:
- Overview of FDA’s metrics of meeting performance under PDUFA VII.
- The FDA’s key meeting management issues and lessons learned from topics that included submission of meeting requests.
- Managing of meeting time efficiently.
- Meeting agendas and meeting background packages.
- Lessons learned from the COVID-19 pandemic.
Industry panelists were also invited to this workshop, and they offered perspectives and suggestions for the FDA to improve formal meeting management. The public workshop and meeting materials are available online at the following link on the FDA’s website: Public Workshop: Best Practices for Meeting Management Under PDUFA VII – 07/22/2024 | FDA
Key PDUFA VII Meeting Performance Takeaways
Key performance takeaways included the following:
- FDA Improving on Meeting Performance: The FDA has improved on achieving its meeting management performance metrics in recent years, especially since the COVID-19 pandemic which impacted FDA resources and capabilities to support meetings. Improvements are most prevalent in FDA hosting or providing written responses to Type C or non-milestone Type B meeting requests. That said, the FDA still has not met the vast majority of overall meeting management goals under PDUFA since 2018. The only meeting management goals that achieved above 90 percent each calendar year are responses to Type A and B meeting requests and issuing final meeting minutes (which is only covering in person or teleconference meetings and does not include written response only meetings).
- New FDA PDUFA VII Meeting Features (Type D & INTERACT): While neither of these new meeting formats had performance metrics available at the time of this conference, the FDA did share the prevalence of receiving these meeting requests. From 2023 until June 2024, the FDA granted 663 out of 858 Type D meeting requests and 113 out of 212 INTERACT meeting requests. While both the FDA and industry have shown appreciation for these formats that further expand sponsor options with FDA meetings, the FDA recognizes that they have issues with their specific purposes, scope, and expectations across both parties. This was particularly evident with the INTERACT format, which many sponsors had meeting requests rejected primarily due to inappropriate topics and questions. The FDA noted that they are receiving fewer INTERACT requests than when it was originally incepted and could be due to the unclear utility of INTERACT meeting versus a Pre-IND meeting. The FDA believes obtaining more experience conducting these new meeting formats will enable them to better define this for sponsors in the future.
FDA Key Meeting Management Issues and Sponsor Recommendations
Issues and recommendations are as follows:
- Understand FDA Meeting Guidance and all related Public Information available. FDA Guidance clearly describes the process for Sponsors to request and attend a formal FDA meeting. Sponsors should review and select an appropriate meeting type based on desired meeting topics and product’s stage of development.
- Clear meeting purpose and objective. Sponsors are still struggling with ensuring their meeting request clearly defines everything FDA needs to grant a meeting. This is the most common reason why the FDA rejects a meeting request or converts it to a different meeting type. Ensure that the meeting request is well-written with a brief purpose statement, where appropriate.
- Focused and Relevant Meeting Questions. It is important that meeting questions are specific and written in a clear and actionable form to ensure that the FDA can provide detailed feedback. Additionally, the FDA advises sponsors to avoid asking more than 10 questions when possible. They also made clear that “subpart questions” (i.e. Part A, B, C, etc.) still count as individual questions. When preparing meeting questions, one specific recommendation is to ensure review of all public information to avoid asking redundant questions that can be addressed via online sources.
- Leverage your FDA Regulatory Project Manager (RPM). FDA emphasized to reach out to your RPM to obtain support for your planned meeting. An RPM can aide you with determining appropriate meeting types, format, desired questions to ask based on meeting scope, and other pointed considerations before proceeding with the request. Additionally, just alerting your RPM of a potential meeting request can be beneficial and the FDA encourages it as an option that sponsors have. For instance, if planning a meeting request with important urgency, an early notification to your RPM may help them with expediting their response time or if accommodations can be anticipated.
Reach out to our Regulatory Strategy team to discuss how to leverage different types of FDA communications throughout your development plan. Our team has worked with multiple sponsors to share best practices around developing meeting requests, briefing documents, and navigating agency meetings to reach an optimal outcome.
For additional background, read previously published articles from MMS that summarize PDUFA VII initiatives and how it impacts FDA formal meetings, as follows:
- Prescription Drug User Fee Act (PDUFA) VII Updates Explained – MMS Holdings
- Updates to FDA Meetings under PDUFA VII – MMS Holdings
This article was written by regulatory leaders within MMS, including Aaron Pyle, Jay Malmo, April Nguyen. To reach them with questions, please email info@mmsholdings.com and we will connect you.