FDA Meetings and EMA Scientific Advice: Which Clock Runs for Which Question

A meeting with a regulator starts with a calendar calculation. Whoever wants an end-of-phase 2 meeting with the FDA submits the meeting package no later than 50 days before the meeting date; whoever seeks a written response to a Type D question sends it with the request. At the EMA, the decision between 40 and 70 days falls on day 30 of the procedure, and the planning phase before that starts around 20 or 45 days before the start according to the guidance's timetable, or around four or eight weeks before according to its submission deadlines.

This article follows the timelines of both authorities along the text: the FDA guidance on formal meetings in its final version of August 2026 and the EMA guidance for applicants in revision 16.

Which six meeting types the FDA has distinguished since August 2026

The guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" has been final since August 13, 2026 (91 FR 52305). It replaces the draft of September 22, 2023, and applies to drugs and biological products regulated by CDER and CBER.

Under section I, it does not apply to abbreviated new drug applications, applications for biosimilar products including interchangeable biosimilars, or submissions for medical devices; footnote 4 excludes meetings with the Office of Generic Drugs, the Office of Compliance and the Office of Prescription Drug Promotion.

Section III lists six types. The Federal Register notice names as changes from the draft additional scenarios for Type D, a clarification on INTERACT and new information on which formats the FDA may grant. The types themselves were already laid out in the draft and in the PDUFA VII framework.

Two rules from section VI belong with this table. Type B and Type B (EOP) requests are honored if the requester is at the appropriate stage of development; an EOP2 request stating that the summary efficacy and safety data from phase 2 will not be in the briefing document will, according to the guidance, likely be denied.

And the FDA generally grants only one of each Type B meeting per application or per group of closely related products. Breakthrough therapy and RMAT products are excepted. Beyond that, the FDA can grant more meetings when separate meetings on unrelated issues would be beneficial; as examples, the guidance names more than one EOP2 meeting for unrelated claims and a separate meeting on manufacturing when the clinical development is on a different timeline. For novel programs with many complex issues, discussion with the division may lead to an agreement that additional meetings are needed.

Which timelines hang on which type

The timelines are in Tables 1, 2 and 4, in Table A of the appendix and in the text of sections VI.B, VIII and XI; Table 3 only covers formats. The figures are calendar days and go back to the PDUFA VII commitment letter for fiscal years 2023 through 2027. The appendix summarizes them as "Meeting Management Procedural Goals", and under section II both FDA staff and requesters are expected to adhere to them; some are requester deadlines, such as the one for the meeting package. In our reading they are not legal deadlines: under section I, guidances in general do not establish legally enforceable responsibilities unless specific regulatory or statutory requirements are cited. One such case is the meeting after a refuse-to-file letter, which 21 CFR 314.101(a)(3) requires before filing over protest.

For Type B (EOP), Type C, Type D and INTERACT, section VIII sets a counter-deadline: the requester notifies the FDA no later than 3 calendar days after receiving the preliminary responses whether the meeting is still needed, and then sends a revised agenda separating resolved questions from those still to be discussed. For Type A and Type B, the requester notifies the FDA "as soon as possible" following receipt of the preliminary responses.

If the requester finds the preliminary responses sufficient, it can ask the project manager to cancel the meeting. If the FDA agrees, the preliminary responses become the final responses and the official record under section IX.

Two footnotes to Table 4 shift the package deadline when the FDA schedules early. If the date of a Type B (EOP) meeting is earlier than 70 days from receipt of the request, the package is due no sooner than 6 calendar days after the 14-day response time; for Type C under 75 days, no sooner than 7 days after the 21-day response time.

If the requester asks for a date beyond the PDUFA window, the FDA should schedule within 14 calendar days of that requested date (section VI.B).

After the meeting, the clock keeps running. The FDA issues the final minutes within 30 calendar days after the meeting; for INTERACT, the preliminary responses are annotated and resent within 30 days if the advice changed as a result of the meeting. For a written response, the response itself serves as the minutes.

Clarifying questions on the minutes or the written response go to the FDA as a "Request for Clarification" within 20 calendar days of receipt. This is meant only for questions that confirm the advice given, not for new issues or new proposals. For questions that meet these criteria, the FDA answers within 20 calendar days. If a question goes beyond that, the division may advise a new meeting request; if it is narrow and focused, the division may still respond in writing at its discretion, without a fixed number of days.

Type D or Type C: where the line is

Type D is the type for the one open question after a meeting, for the narrow issue with a few associated questions, and for the general question about an innovative development approach that does not require extensive advice. The guidance draws the line at two numbers: no more than two focused topics, and the topics must not require input from more than three disciplines or divisions. For the narrow issue with a few associated questions, it gives three to five questions in total as an example.

Whoever has more than two topics, or a single highly complex issue with many questions, should according to the text request a Type C meeting. Several Type D requests in temporal proximity instead of a single Type B or Type C meeting are expressly not wanted.

If the scope is nonetheless broad, if the request needs more than three disciplines, a cross-center response or additional regulatory review, the FDA informs the requester that it will convert the meeting to Type B or Type C. The requester can withdraw the request or accept the conversion without resubmitting.

The examples in section III.E show what the type is meant for: a specific question about one aspect of a complex or innovative trial design, a question about presenting data after a pre-BLA or pre-NDA meeting, a follow-up question on a new issue from a previous discussion, a question about a single element of a phase 3 design already discussed.

Added to this are questions on a nonclinical protocol after the pre-IND meeting and clarification of a limited number of comments from a meeting held more than 20 calendar days earlier. The benefit lies in the clock: 14 days until the response to the request and 50 days until the meeting, instead of 21 and 75 for Type C.

INTERACT: the window before the pre-IND meeting

INTERACT stands for "Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs" and is intended under section III.F for novel products and programs where an early question would otherwise delay first-in-human testing.

The guidance gives as examples the choice of nonclinical models and the design of IND-enabling toxicology studies for new platforms, questions on complex manufacturing technologies, testing strategies for product safety before a first-in-human trial, innovative devices used with a drug, and the use of New Approach Methodologies.

The window is narrow. INTERACT meetings are typically held before a pre-IND meeting; whoever has already had a pre-IND meeting or filed an IND is, according to the text, at the wrong type. The requester must also have selected a specific investigational product or a product-derivation strategy before requesting. Within scope, the guidance lists two groups: questions for which there is no existing guidance or other written FDA information the requester could reference, and issues to be addressed before a pre-IND meeting; as the last example point under that heading, it names other topics that would be agreed upon by the FDA.

The response and scheduling timelines are the same as for Type C: 21 days until the response, 75 days until the meeting, preliminary responses 5 days ahead. The meeting package, however, comes with the request for INTERACT, while for Type C it is generally due no later than 47 days before the meeting. What differs is the follow-up: instead of minutes, the FDA annotates its preliminary responses and resends them within 30 days if the advice changed during the discussion.

Written response instead of a meeting: who decides

Section IV knows four formats: hybrid in person, virtual with cameras on, teleconference and written response only. The requester can request any format for any type, but the FDA determines type and format.

Table 3 splits the types into two groups. For Type A, Type B other than pre-IND, and Type B (EOP), the FDA grants a written response only if the requester asked for it. For the pre-IND meeting, Type C, Type D and INTERACT, the FDA may grant a written response if appropriate, regardless of the format requested.

For this second group, section VI names the way back to a discussion: the requester can explain in a follow-up correspondence to the division why a meeting is needed, and the FDA considers whether to change the format. Under Table 2, the timelines for a written response are the same as for scheduling the corresponding meeting type.

In the meeting itself, an FDA staff member chairs, audio and visual recording is prohibited, and presentations by the requester are, under section X, usually unnecessary because the information should be in the meeting package.

If a presentation contains more than a small amount of new material that was not in the package, the FDA may not be able to comment. Discussion points, agreements, clarifications and action items are summarized at the end of the meeting or after the discussion of each question, generally by the requester; FDA staff can add or further clarify points, and these can be added to the minutes.

What carries the request: no more than ten questions

Section V requires the request to state the format, the date the meeting package will be sent, a brief statement of purpose and background that makes the issues understandable (the guidance gives a table summarizing major results as an example), an agenda with time estimates, the requester's attendee list including consultants and interpreters if applicable, and the requested FDA attendees.

In addition, the request should include the application number if previously assigned, the product name, the structure as appropriate, the proposed regulatory pathway (for example 505(b)(1), 505(b)(2), 351(a)), the indication, the meeting type, the expected outcomes, proposed dates and the list of questions, plus pediatric study plans, a human factors plan and combination product information, each if applicable.

According to the text, the list of questions is one of the most critical parts of the request, because the FDA uses it to gauge the expertise needed and the feasibility within the type's time frame.

Recommended are no more than ten questions including subquestions, each with its own number and grouped by discipline, with a brief explanation of context and purpose. Whoever asks for additional FDA attendees who are not essential to answer the questions should justify this and say whether a later date is acceptable.

The meeting package repeats the information in the request and, under section VII.C, adds the development history with prior FDA communications, substantive changes to the plan, the current status, the final questions and the data by discipline and question. Protocols, full study reports and detailed data generally do not belong in it; expected are summarized results with some degree of quantification, the endpoints, and whether endpoints or analyses were changed during the trial.

For an EOP2 meeting, the guidance gives as an example what this part of the package should include: controlled trials on dose-response, summary efficacy and safety data from phase 2, the planned phase 3 trials with population, eligibility criteria, design (with the basis for any noninferiority margin if a noninferiority trial is used), dosage, endpoints, safety monitoring and analyses including interim analyses and adaptive features.

A package not received within the time frames or grossly inadequate is, under section IX, an example of when a meeting can be canceled; a subsequent request then counts as a new request with a new clock. Rescheduling, by contrast, needs no new request. As examples of rescheduling, the guidance names among others a delay in submitting the package, a voluminous package despite timely submission, questions or data sent after the package, and the unavailability of essential attendees. Whether a meeting is rescheduled or canceled is at the discretion of the review division.

And at the EMA: 40 or 70 days, decided on day 30

The legal basis of scientific advice is Article 57(1)(n) of Regulation (EC) No 726/2004: one of the tasks of the Agency is "advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products". EMA guidance EMA/4260/2001 Rev. 16 of March 26, 2025, makes clear that advice may be requested for all medicinal products for human use, irrespective of eligibility for the centralized procedure.

Protocol assistance is the form for orphan medicinal products under Article 6 of Regulation (EC) No 141/2000. There, questions on significant benefit and on similarity or clinical superiority over other orphan medicines are added. Under question 4 of the guidance, the COMP is involved alongside the CHMP in the questions on significant benefit.

Under question 24 of the guidance, the procedure has two phases. In the planning phase, the applicant submits a draft briefing document via IRIS, around 45 days before the start if a preparatory meeting is wanted, around 20 days without. The Agency reviews previous procedures, EPARs and earlier advice, appoints experts and sends comments; the applicant revises, and at about day minus 5 the package is validated. Question 17 sets the submission deadline somewhat differently, at approximately 8 or 4 weeks before the intended start.

Day 0 starts the evaluation phase. On day 20, the first reports of the two coordinators from the Scientific Advice Working Party are available; on day 30, the SAWP discusses the controversial issues and decides whether the advice can be adopted on day 40 or whether a discussion meeting is necessary. The Agency communicates this decision at the end of that SAWP meeting; the applicant should ensure that its experts are available around day 60.

Without a meeting, the coordinators send their joint report on day 33, and the CHMP adopts the advice letter on day 40. With a meeting, the discussion takes place around day 60, the joint report follows on day 63 and the advice letter on day 70. In rare cases the SAWP asks for written answers only instead of a meeting; the 70-day procedure then applies as well.

Whoever is invited receives a list of issues, split into those to be addressed at the meeting and those to be answered in writing beforehand, and may add points of its own no later than a week before the meeting, provided they relate to the request submitted.

The record works differently from the FDA. The applicant provides its own minutes 2 working days after the discussion meeting; they are regarded as the applicant's record and are not endorsed by the SAWP. What counts is the CHMP's advice letter.

It is not binding either: under question 26, the advice does not bind the Agency or the applicant with regard to a future marketing authorization application. In question 1, the guidance adds that how closely the advice was followed is taken into consideration during the assessment and that deviations need to be well justified; question 26 asks applicants who choose not to apply the advice to clearly justify their position in the marketing authorization application.

According to the EMA overview page, every assessment report finalized after January 1, 2019, includes a summary of the questions, the key elements of the advice and whether the developer complied with it.

What the EMA does not answer is also on the overview page: ATMP classification, PRIME eligibility, accelerated assessment and compassionate use run in their own procedures, as do changes to the key elements of pediatric investigation plan (PIP) measures and pediatric waivers or deferrals; matters of a purely regulatory nature do not belong in scientific advice; and whether existing data are adequate for an application is a question for that application.

The page's example hits the interface with the FDA: "Are the non-clinical data adequate to support a first-in-human study?" is, according to the EMA, not a scientific advice question but a question for the clinical trial application under national competent authority remit. At the FDA, by contrast, the design of IND-enabling toxicology studies is a core case for INTERACT. The design question itself (which models, which endpoints) the EMA accepts as a non-clinical aspect; the adequacy question it does not.

What follows for preparation

The calculation starts at the decision point in the project and runs backwards. For an EOP2 meeting, up to 70 days lie between request and meeting date, the package must be in 50 days before the meeting, and the phase 2 data must be summarized in it; whoever files the request before the data are secured risks denial under section VI.

For a single follow-up question after that meeting, Type D at 50 days is the faster route, but only if the question fits into two topics and three disciplines.

On the EMA side, the planning phase decides the total duration. A preparatory meeting costs around 25 more days of lead time according to the timetable, or around four more weeks according to the submission deadlines in question 17, but brings the Agency's list of comments on the briefing document before the clock starts. After that, the procedure takes 40 days without and 70 days with a discussion meeting or with the rare written-only list of issues; whoever wants to consult both authorities in parallel will find the note in the guidance that discussion meetings are part of the procedure by default for parallel EMA-FDA advice.

On both sides, the document the applicant writes is the real work: at the FDA, the numbered list of no more than ten questions and the package organized by agenda; at the EMA, the briefing document with questions and proposed answers. What is missing there is missing from the record. For a new issue, the FDA guidance points to a new meeting request, a WRO request or a submission with specific questions; the request for clarification within 20 calendar days is meant only for questions that confirm the advice given. At the EMA, the applicant may request a clarification after the advice letter if the advice is perceived as not being clear or precise enough; question 27 sets no deadline for this, and new data or a new position would normally require new advice.

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