Getting timely, clear feedback from the Food and Drug Administration (FDA) can shape the trajectory of your entire development program. But requesting the right meeting and preparing for it strategically makes all the difference.
Formal meetings with the FDA are one of the most valuable tools available to drug and biologic sponsors. They give you a direct channel to the agency’s thinking on your development plan, your data, and your path forward. Used well, they can clarify regulatory expectations, prevent costly missteps, and keep your program on track.
The FDA outlines several formal meeting types, each with its own purpose, scope, and timeline. Choosing the right meeting depends on where you are in development, what kind of feedback you need, and how quickly you need it. Once you’ve chosen, the quality of your meeting package is what determines whether you walk away with actionable guidance or vague responses that leave your team guessing.
Before we dive in, let’s first define our terms:
- A meeting request is the document sent to the FDA to request a meeting. It’s relatively short, covers logistics, and gives a brief overview of the topics that a Sponsor wants to discuss with the agency.
- A briefing document (also known as a briefing book) is the main component of a meeting package. This document includes background information, questions for the agency, the Sponsor’s positions or rationales for the questions posed, and supporting data for the discussion. The briefing document is usually the most time-intensive part of preparing for FDA meetings and usually requires major writing and project management resources.
- A meeting package is the totality of the briefing document and all other components of the submission. Other components might include appendices, study manuals, protocols or protocol synopses, supporting data, and anything else a regulator may need to provide meaningful answers to the Sponsor’s questions.
Here’s what clinical development teams should know about each meeting type, along with some practical considerations for getting the most out of your interactions with the FDA.
Type A Meetings: Resolving Stalled Programs and Safety Issues
Type A meetings are reserved for situations in which a program has stalled or when an important safety issue needs to be addressed. If the FDA has placed a clinical hold on your study, if you’re navigating a dispute-resolution process, or if you’ve received a refusal-to-file letter and need to understand the path forward, a Type A meeting is the appropriate request.
Because these situations are urgent, the FDA responds quickly. The agency aims to respond to a Type A meeting request within 14 days and schedules the meeting within 30 days of receiving the request. The meeting package is submitted at the same time as the meeting request, so your preparation needs to be front-loaded.
Type B Meetings: Milestone Discussions That Shape Your Program
Type B meetings are the milestone meetings most clinical development teams are familiar with. These meetings mark major inflection points in your program and include: pre-investigational new drug (IND) application, end-of-phase, and pre-new drug application (NDA)/pre-biologics license application (BLA) meetings.
The FDA responds to Type B meeting requests within 21 days and schedules the meeting within 70 days of the request. The meeting package is due no later than 30 days (standard Type B meeting) or 50 days (end-of-phase meeting) before the meeting.
Type B meetings are high-stakes interactions. For example, for an end-of-phase 2 meeting, a well-prepared meeting package can secure alignment on your pivotal study design. A strong pre-NDA meeting can surface potential issues before you’ve committed the resources to compile an entire submission.
Type C Meetings: Cross-functional Advice at Other Times in Drug Development
Type C meetings may cover broad topics at any stage of clinical development
Timelines for Type C meetings are slightly longer. The FDA aims to respond to a Type C meeting request within 21 days and schedules the meeting within 75 days of the request. The meeting package is due no later than 47 days before the scheduled meeting date.
Type D Meetings: Focused Feedback on a Shorter Timeline
Type D meetings are a relatively recent addition, introduced under Prescription Drug User Fee Act (PDUFA) VII and detailed in the FDA’s 2023 draft guidance on formal meetings. They’re designed for Sponsors who need focused input on a narrow set of issues, without the scope and overhead of a full Type B or Type C meeting.
Here’s what makes them distinctive:
Scope is limited by design. Type D meetings should address no more than 2 focused topics and require input from 3 or fewer FDA disciplines or divisions. The guidance suggests sponsors can include 3 to 5 focused questions, assuming that extensive, detailed advice isn’t required.
The meeting request and meeting package are combined. Unlike Type B and Type C meetings, where request and package are separate submissions with staggered timelines, Type D meetings consolidate both into a single document. From a writing standpoint, that’s a meaningful efficiency. It streamlines the preparation process and reduces the total number of cross-functional cycles your team needs to manage.
The timeline is faster. The FDA aims to provide a response (either a scheduled meeting or written responses) within 50 days of the request. That’s faster than Type B or Type C meetings, making it a good option when you need timely guidance to keep moving.
A word of caution: If your meeting request exceeds the Type D criteria (too many questions or input is needed from more than 3 disciplines), the FDA may convert it to a Type B or Type C meeting. In that case, you can either accept the conversion (no new meeting request required) or withdraw the request. The FDA also discourages requesting multiple Type D meetings in a short span, as this usually signals the topics are better suited to a more comprehensive meeting type.
Practical Tips for Preparing Your FDA Meeting Package
Regardless of the meeting type, the quality of your meeting package is what drives the quality of the FDA’s response. A well-organized, clearly written briefing document gives the agency the context they need to provide specific, actionable feedback. A poorly prepared briefing document that’s vague, disorganized, or asks questions without sufficient background can result in generic responses that don’t move your program forward.
Here are a few tips we’ve learned from supporting briefing documents and meeting packages across our clients’ programs:
Write a stable draft of the briefing document before submitting the meeting request. This advice applies to Type B and Type C meetings, where the meeting request and package are submitted on staggered timelines. Teams often feel pressured to submit the meeting request as fast as possible. But once it’s submitted, the clock starts ticking on the meeting package, which can require a massive effort to write and finalize under the time constraints.
Drafting the briefing document first allows you to identify any gaps and potential impact of forthcoming results; coordinate development of dependencies like a protocol or statistical analysis plan that may be needed for the meeting package; decrease the effort on the meeting request itself since relevant elements can be pulled from the stable briefing document; and give yourself plenty of time to finalize the meeting package after the meeting request is submitted.
All in all, the advantage you might gain by rushing the meeting request could end up compromising the quality of your meeting package, and with it, the quality of FDA’s feedback. So, take the time to write the first draft of the briefing document before your meeting request is submitted.
Let your questions drive the structure. The briefing document should be organized to support the specific questions you’re asking. Everything should connect back to giving the FDA the context they need to respond thoughtfully. Avoid the temptation to include exhaustive background information that doesn’t directly support a question. It increases the review burden on the agency without improving the quality of their responses.
Keep the question count manageable. The 2023 draft guidance stipulates that meeting requests should contain no more than 10 total questions, including sub-questions. That is, sub-questions like 1a, 1b, and 1c count as separate questions, not one.
Plan for cross-functional input early. Briefing documents and meeting packages may require cross-functional contributions from clinical, regulatory, biostatistics, chemistry, manufacturing, and controls (CMC), and nonclinical teams. While it’s good to strategize questions and positions before writing begins, the writing process itself often surfaces gaps and misalignments in the team’s thinking. Starting early, even while some details may still be in flux, gives your team the opportunity to work through strategic questions early in the writing process.
Choosing the Right Meeting Type
Selecting the appropriate meeting type isn’t always straightforward, especially when the boundaries between categories feel blurry. Here’s a quick way to think about it:
If your program is stalled or there’s an urgent safety issue, request a Type A meeting.
If you’re at a major development milestone (pre-IND, end-of-phase, pre-NDA/pre-BLA), request a Type B meeting.
If you have numerous cross-functional development questions that don’t align to the timing of a Type B milestone meeting, request a Type C meeting.
If you need focused advice on 1 or 2 specific topics and can keep the scope narrow, consider a Type D meeting. It’s a faster time to FDA feedback, and the combined request/package format makes preparation more efficient.
Regardless of which meeting type you choose, the investments you make in your briefing document and meeting package are the biggest factors in the quality of feedback you receive. A thoughtful, well-written package reflects the seriousness and rigor of your program and gives the FDA the best possible foundation for providing the guidance your team needs to move forward with confidence.
Get Strategic Support for Your Next FDA Meeting Package
Preparing for a regulatory interaction is one of the highest-stakes writing projects your team will take on. The questions you ask, the data you present, and the way you frame your development strategy all shape the feedback you receive, and that feedback shapes the path forward for your program and the patients who are counting on it.
If your team is stretched thin, navigating this process without dedicated medical writing support can lead to a scramble when pulling a meeting package together under pressure, sacrificing the strategic focus these documents deserve. Medical writers who already understand your program’s regulatory history, study design rationale, and development goals can help you build a cohesive, well-structured briefing document and meeting package that tells your product’s story clearly for the most actionable FDA feedback.
Eldridge Writing & Consulting LLC partners with clinical development teams to author briefing documents and meeting packages for global regulatory agency meetings. As an ongoing partner, we get to know your program so that when a regulatory milestone approaches, we’re ready and prepared to be your strategic medical writing partners. No matter what milestone is upcoming for your clinical development team, we’d love to connect and talk through how we can support you.
