Understanding FDA meetings has become clearer and more exciting with the introduction of the ‘Type D’ meeting format under PDUFA VII. Introduced on October 1, 2022, this new format is designed to make specific interactions between sponsors and the FDA faster and more straightforward. We’ve discussed its details in an earlier white paper. Building on our recent experiences since its introduction, we now offer a user-friendly guide. For those looking to benefit from this new format, it’s essential to understand its main features, requirements, and possible challenges. Join us as we break down the ins and outs of Type D meetings, sharing our firsthand experiences and tips for success.
The FDA has announced plans to update the draft guidance titled “Formal Meetings Between the FDA and Sponsor or Applicants of PDUFA Products” by September 30, 2023. This revision will encompass details about the Type D and INTERACT meetings. According to the PDUFA VII commitment letter, the Type D meeting is especially suitable in situations like:
- Raising a follow-up question after a formal FDA meeting that introduces a new topic, which goes beyond just seeking clarity from a previous discussion.
- When a sponsor wants FDA feedback on a specific, limited topic with just a couple of related questions.
- Posing a broad query about an innovative advancement that doesn’t require comprehensive guidance.
Since the introduction of this new meeting format, MMS has actively collaborated with numerous sponsors to initiate Type D meetings, including those that require just a written response only (WRO) as well as those that wish to interact via a teleconference. According to Senior MMS Regulatory Specialist Jim Hinson, the meeting type has met with an enthusiastic response: “I have found the Type D meetings to be a quite useful forum to obtain focused information in a reasonable amount of time.” Jim also notes “The process has already benefited both small and large companies alike.” Drawing from our recent interactions with the Type D meetings, we’d like to share some vital tips to prevent potential delays in securing FDA feedback.
1. Accurately Determine Your Disciplines
For a meeting to qualify under the Type D format, it’s important to note, as per the PDUFA VII commitment letter, that the Type D meeting shouldn’t necessitate input from over 3 FDA disciplines or Divisions. This count is for the entire request, not per individual question. For instance:
- Sub-question 1 addresses Chemistry, Manufacturing, and Controls (CMC)
- Sub-question 2 pertains to Nonclinical matters
- Sub-question 3 revolves around Clinical Pharmacology and Clinical studies
In the above scenario, even though the sponsor only has three sub-questions, they touch upon at least 4 FDA disciplines. Consequently, the FDA might determine that it doesn’t qualify for a Type D meeting. Should this happen, the FDA could suggest switching to a more fitting meeting type (like Type B or C) or ask the Sponsor to withdraw their request.
Furthermore, sponsors should be aware that the FDA might have a different perspective regarding the count of disciplines or Divisions needed for the meeting. If the FDA believes more representation is necessary than the sponsor initially anticipated, the meeting request could face a denial. This could happen even if the sponsor didn’t initially request a meeting involving more than three disciplines or Divisions, but the FDA deems additional divisional support essential due to the nature of the questions.
2. Be Strategic with Your Background Package
When pursuing Type D meetings, it’s crucial not to overwhelm with too detailed or intricate background materials. If the background package you submit for a Type D meeting contains information so extensive that it requires the involvement of more than three FDA disciplines or Divisions for review, the FDA might advise you to retract your Type D request and opt for a more suitable meeting format.
To navigate this, ensure your Type D background materials are thorough enough to fully encapsulate the issue, yet streamlined to avoid necessitating a review by more than three FDA disciplines or Divisions. Achieving this balance requires meticulous planning and synergy within the sponsor team.
3. Prepare for Alternatives
In instances where the FDA deems your questions or issues unsuitable for a Type D meeting, they might suggest converting your meeting to a Type B or Type C. Alternatively, they could advise you to withdraw the Type D meeting request and submit a new one. If you’re open to this transition from Type D to another meeting type, ensure the package you present is versatile enough to accommodate both meeting requests.
Remember, the packages typically required for Type B or C meetings are more expansive than those for Type D. They demand a more detailed meeting package, often necessitating supplementary safety data or additional background information relevant to all the FDA divisions involved. This is particularly the case for Type B and C meetings. Balancing the information becomes critical; an overload or shortage of data can derail your meeting request.
At MMS, we emphasize the importance of a backup strategy. It’s essential to have a contingency plan in place to minimize potential disruptions to product development when preparing these materials.
While the Type D meeting format offers an appealing avenue to gain quick feedback on specialized topics, it’s vital for sponsors to be mindful of FDA guidelines and the intricacies involved. This includes taking a holistic approach, foreseeing the range of FDA disciplines that might be necessary for a thorough assessment, and ensuring that questions are clearly framed. Prior to opting for a Type D meeting, we urge sponsors to practice restraint and meticulously evaluate the primary issues requiring clarity. They should also consider what it entails for the FDA to provide answers and always have a backup plan ready, should the FDA deem the provided materials unsuitable for a Type D format.
Amanda Beaster, Associate Director, Regulatory Strategy
Nancy Hsu, Regulatory Affairs Associate II
Interested in understanding more about Type D FDA meetings? Please click here to start a conversation with our regulatory experts now.