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FDA Meeting Timeline Calculator

Plan a PDUFA meeting end to end. Start from the date you file, or from the date you need an answer, and get every deadline in between.

  • Flag deadlines that land on a weekend or federal holiday.
  • Compare all 6 meeting types side by side.
  • Export every milestone to your calendar.
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The Bracken Group FDA Meeting Timeline Calculator
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What kind of meeting do you need?

The comparison table in your results will show what each type would mean for your dates.

Note: if you are unsure between Type C and Type D, Type D is limited to two focused topics needing input from no more than three disciplines or divisions, and FDA can convert a request that exceeds that.

Select your meeting type

Your timeline

 
 
 

Your deadlines

 

What FDA owes you

 

What a different meeting type would mean

 
Read these as ceilings, not appointments. The guidance commits FDA to acting within each interval, not on the final day, so a meeting may be granted and scheduled earlier than the date shown. All intervals are calendar days, so a deadline can land on a weekend or federal holiday; where it does, the date is flagged with the business day to act by. This tool is a planning guide and does not account for every variable in an individual program.

Sources

  1. 1.Table 1 — FDA response to a meeting request. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, final guidance, August 2026. Download the guidance (PDF)
  2. 2.Table 2 — Meeting scheduling and WRO response time frames. WRO response times are identical to meeting scheduling times for each meeting type.
  3. 3.Table 3 — Formats FDA may grant. For Type A, Type B other than pre-IND, and Type B (EOP), FDA issues a written response only when the requester asked for one. For pre-IND Type B, Type C, Type D and INTERACT, FDA may grant a WRO regardless of the format requested.
  4. 4.Table 4 — Requester meeting package timelines. Due with the request for Type A, Type D, INTERACT and surrogate-endpoint Type C. Otherwise 30 days before for Type B, 50 days for Type B (EOP), 47 days for Type C.
  5. 5.Table 4, footnotes — Package floor for near-term meetings. If a Type B (EOP) meeting is scheduled sooner than 70 days from receipt, the package is due no sooner than 6 calendar days after FDA's response deadline. For Type C scheduled sooner than 75 days, no sooner than 7 calendar days after.
  6. 6.Section VIII — Preliminary responses. No later than 5 calendar days before the meeting for Type B (EOP), Type C, Type D and INTERACT; no later than 2 calendar days before for Type A and Type B. Not applicable to a WRO.
  7. 7.Section VIII — Requester response to preliminary responses. No later than 3 calendar days after receipt, for Type B (EOP), Type C, Type D and INTERACT. The requester confirms whether the meeting is still needed and sends a revised agenda.
  8. 8.Section XI — Meeting minutes. FDA issues official finalized minutes within 30 calendar days after the meeting. For INTERACT, preliminary responses are annotated and resent within 30 days. Where a WRO is issued, the written response serves as the minutes.
  9. 9.Section XI — Request for Clarification. Clarifying questions should be sent in writing within 20 calendar days following receipt of the meeting minutes or WRO, and FDA responds within 20 calendar days of receipt.
  10. 10.Federal Register — Notice announcing the final guidance, August 13, 2026. federalregister.gov
  11. 11.Federal holidays — Weekend and holiday flags use the eleven U.S. federal holidays and the standard observed-day rule, where a Saturday holiday is observed the preceding Friday and a Sunday holiday the following Monday. The guidance counts calendar days, so a flagged deadline does not move; only your practical filing date does.

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