A meeting package is the document you send FDA ahead of a formal meeting so the agency can prepare its answers to your questions. Most people in industry call it a briefing book, or a briefing document. FDA calls it a meeting package, and that is the term used throughout the guidance that governs it, so it is the term used here.
It is one of the most consequential documents a regulatory writer produces and one of the least taught. A Clinical Study Report reports something that already happened. A meeting package asks for advice that will shape what happens next, and the answers it draws become part of the written record of your development programme. Those answers get quoted back years later, which is why the drafting deserves more care than it usually gets.
The controlling document is FDA's guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, finalised in August 2026 under docket FDA-2017-D-6530. It covers drugs and biologics regulated by CDER and CBER. It does not cover generics, compliance matters, or promotional review, and medical devices run a separate Q-submission process.
One framing point before the detail. The guidance is nonbinding: every page carries the line "Contains Nonbinding Recommendations." What follows is what FDA recommends and what its review divisions expect, not a set of legal requirements.
Two documents, not one
Almost everyone conflates the meeting request with the meeting package. They are separate submissions with different content and, notably, different language in the guidance.
For the meeting request, the guidance says it "must include the following information," a formulation traceable to the PDUFA commitment letter. For the meeting package, it says packages "generally should include" the listed information. The request is the harder floor.
The request must carry the proposed meeting format, the date the package will be sent, a brief statement of purpose, a proposed agenda with time estimates, your attendee list, and your requested FDA attendees or disciplines. It must also carry the application number, product names, chemical name and structure, proposed regulatory pathway such as 505(b)(1), 505(b)(2) or 351(a), proposed indications, the meeting type, your specific objectives, pediatric study plans, a human factors engineering plan and combination product information where applicable, suggested and unavailable dates, and a list of precise proposed questions grouped by FDA discipline.
For some meeting types the package goes in with the request, so the distinction collapses in practice. That is the case for all Type A meetings, all Type D meetings, all INTERACT meetings, and Type C meetings requested as early consultations on a new surrogate endpoint.
When the package is due
The deadline depends on the meeting type, and it is a writing calendar rather than an administrative footnote.
| Meeting type | Package due |
|---|---|
| Type A, Type D, INTERACT, Type C (new surrogate endpoint) | At the time of the meeting request |
| Type B | No later than 30 days before the meeting or WRO response |
| Type B (EOP) | No later than 50 days before the meeting or WRO response |
| Type C | No later than 47 days before the meeting or WRO response |
Two adjustments apply where meetings are scheduled early. If a Type B (EOP) meeting falls earlier than 70 days from FDA's receipt of the request, the package is due no sooner than 6 calendar days after FDA issues the letter granting the meeting. If a Type C meeting falls earlier than 75 days from receipt, the package is due no sooner than 7 days after that letter.
The practical consequence for an end-of-phase 2 meeting is that the package is finished roughly seven weeks before anyone sits down. Whatever data you hoped to include has to exist well before that.
Packages are submitted as an archival submission to the relevant application through the electronic gateway, or in CDER through the CDER NextGen Portal.
What goes in the package
The guidance lists six content items, "preferably in the order listed," on top of the items already in the request.
- Attendees. Names, titles and affiliations of everyone attending from your organisation, including consultants and interpreters.
- A background section. A brief history of the development programme and relevant communications with FDA before the meeting; any substantive changes to the development plan; and the current status of development.
- A statement of purpose, identifying the meeting type.
- A proposed agenda, with estimated time for each item.
- The questions. Up to ten in total including subquestions, grouped by FDA discipline, each with a brief summary explaining the need or context for the question.
- Data to support discussion, organised by discipline and by question.
Item 2 is the one worth pausing on. You are being asked to write the history of what FDA has already told you, and file it with FDA. A background section that summarises prior advice selectively is transparent to a review team holding the original minutes. Write it as though the reader has those minutes open, because they do.
The guidance also sets a general standard for the whole package: "It is critical that the entire meeting package content support the intended meeting objectives." Two specific expectations follow from that. Where your development plan "deviates from current guidances, or from existing precedent, the deviation should be identified and explained." And "known difficult design issues and questions about providing substantial evidence of effectiveness should be raised for discussion." Neither is optional in spirit. Both mean surfacing your weakest point rather than routing around it.
The questions are the document
FDA is explicit that the question list "is one of the most critical aspects of the meeting request," because it determines which agency experts attend, whether the questions can be answered in the time allotted, and what the meeting actually covers.
Three rules govern it.
Ten total, including subquestions. The cap is not ten headline questions with parts underneath.
Each subquestion gets its own number. This is the part most teams get wrong, and the guidance spells it out: if Question 1 has three parts, number them 1, 2 and 3 rather than 1a, 1b and 1c. If you have three nonclinical and three clinical questions, they are numbered Nonclinical 1, 2, 3 and Clinical 4, 5, 6. The familiar workaround of nesting six questions under two headings does not survive this rule.
Numbering carries across documents. The guidance asks that the numbering and scope of each question in the meeting request be similar to the numbering and scope in the package. Renumbering or quietly rescoping questions between the two is visible.
Beyond the mechanics, every question carries a short piece of prose explaining its context and purpose. That requirement changes the writing task. You are not listing questions; you are arguing your way to each one, which is the same discipline as moving from a one-line indication to a cited synopsis. A question with no explanation reads as a question you have not thought through.
Two practical consequences. First, with ten slots and typically one Type B meeting per application, question selection is a strategic act, not an editorial one. Second, grouping by discipline means your clinical, CMC and statistical questions each stand alone in front of a different reviewer, so each needs its own self-sufficient context.
Writing the data section
This is where packages most often go wrong, because the instinct is to include everything.
The guidance is direct: "Protocols, full study reports, or detailed data generally are not appropriate for meeting packages." What is wanted is summarised material describing results "with some degree of quantification."
Two sentences in that passage function as drafting instructions:
The trial endpoints should be stated, as should whether endpoints were altered, or analyses were changed during the course of the trial.
Merely describing a result as significant does not provide the review division with enough information to give the most constructive advice or identify important problems the requester may have missed.
The first is a disclosure expectation inside a summary document. If your endpoints moved or your analysis changed mid-trial, the package is where you say so. The same reconciliation problem appears whenever an analysis population changes late and every downstream document has to be brought into line.
The second rules out the most common failure in these documents, which is reporting conclusions instead of results. "The primary endpoint was met" tells a reviewer nothing they can advise on. Effect size, confidence interval, the analysis population and the comparator do.
For an end-of-phase 2 package the guidance gives a worked example of what this section should contain: dose-response results, summary efficacy and safety data from phase 2, and adequately detailed descriptors of the planned phase 3 trials, including population, critical eligibility criteria, trial design and choice of control, the basis for any noninferiority margin, dosage selection, primary and secondary endpoints, major safety concerns with the monitoring plan, and major analyses including interim analyses and adaptive features. In practice much of that is drawn straight from protocol drafting already under way.
Format: a document, not a bundle
The guidance asks that package content be "organized according to the proposed agenda" and describes the artefact itself:
The meeting package should be a sequentially paginated document with a table of contents with appropriate electronic linkage, appropriate indices, appendices, and cross references.
The stated purpose is to "enhance reviewers' navigation across different sections within the package, both in preparation for and during the meeting."
That is a drafting requirement, not a publishing one. A package assembled as separate files and merged at the end will not have working internal linkage, which is the argument for treating cross-references as part of the draft rather than a final production step. Assume your reviewer is moving around the document live while the meeting is happening.
Length is its own failure mode
Three provisions in the guidance turn on package quality, and they escalate.
A meeting can be rescheduled where "the review team determines that the meeting package is inadequate," and also where "there is insufficient time to review the material because the meeting package is voluminous." The guidance is careful to note that this can happen "despite submission within the specified time frames and the appropriateness of the content." Volume alone is a risk, even when everything in the package is correct and on time.
A meeting can be cancelled where the package is "grossly inadequate."
A meeting request can be denied where the package "does not provide an adequate basis for the meeting discussion," or where the request is premature for the stage of development. FDA gives the example of an end-of-phase 2 request stating that phase 2 efficacy and safety data will not be available in the briefing document; that request "will likely be denied."
Against all of that, the guidance is explicit that denials "will be based on a substantive reason, not merely on the absence of a minor element." The thing to avoid is not an imperfect package. It is an unreadable one.
What happens after you send it
The writing does not stop when the package goes in.
Preliminary responses. FDA sends written responses to your questions no later than 5 calendar days before Type B (EOP), Type C, Type D and INTERACT meetings, and no later than 2 calendar days before Type A and other Type B meetings.
A revised agenda. For the first group you then have 3 calendar days to say whether the meeting is still needed and, if it is, to send a revised agenda marking which questions you consider resolved and which you still want to discuss. That is a drafting task on a three-day clock, and the guidance notes it "could alter the core attendees from the FDA." Adding new data at this stage does not work: preliminary responses "are not intended to generate the submission of new information or new questions," and new material may go without comment.
The meeting itself. Presentations are "usually unnecessary because the information necessary for review and discussion should be part of the meeting package," and new content in a presentation that was not in the package may draw no commentary. At the end, the requester will generally be asked to summarise the discussion, advice and agreements aloud; FDA can add to that summary, and those items can go into the minutes.
Minutes. FDA issues finalised minutes within 30 calendar days, in bulleted form, not as a transcript. FDA may include material in the minutes that was never discussed, such as pediatric requirements, data standards or abuse liability, and will distinguish it from the discussion.
Two written routes if something is wrong. On a significant difference in understanding, raise it with the project manager and, if it persists, submit a description of the specific disagreements to the application. The minutes then either stand or receive an addendum, which will also record any remaining objections. Separately, clarifying questions may be sent as a Request for Clarification within 20 calendar days of receiving the minutes, confined to confirming advice already given, with FDA responding in writing within 20 calendar days.
Both routes are short and both close.
A working checklist
- The request and the package are separate submissions; check which of your meeting types requires them together.
- Count your questions including subquestions. Ten is the ceiling.
- Number subquestions individually: 1, 2, 3, not 1a, 1b, 1c.
- Group questions by FDA discipline and keep numbering consistent between request and package.
- Give every question a short context paragraph.
- Write the background section as though the reader has your prior meeting minutes open.
- Identify and explain any deviation from guidance or precedent.
- State whether endpoints were altered or analyses changed mid-trial.
- Quantify results; never write that something was significant and stop.
- Build the table of contents, cross-references and internal links while drafting.
- Cut length aggressively. Voluminous is a stated reason to reschedule.
- Diary the three-day revised-agenda window and the twenty-day clarification window before the meeting happens.
Related reading
For where meeting packages sit among everything else you will write, see the guide to regulatory documents in drug development and the CTD explained. For the guidelines that govern neighbouring documents, see ICH guidelines every regulatory writer should know.
For an analysis of what this guidance implies for how packages are drafted, see Ten Questions, One Type B Meeting. For a worked example of meeting minutes returning years later as evidence, see the TUDRIQEV record, where FDA quoted a March 2021 Type B meeting back to the sponsor in a 2026 rejection letter.