FDA Meeting Request Calculator

We at Bracken developed this calculator to provide you with a clearer understanding of the timing and steps required to get an FDA meeting granted on the timeline that fits your program. Please note, however, that the information generated is only a guide. The calculations cannot take into account all possible variables and outcomes.

How to use this tool

Step 1
Select the type of meeting that you require: Type A, Type B, Type C, or Type D.

  • Type A meetings are for dispute resolution or to address a clinical hold
  • Type B meetings are milestone meetings (pre-IND, EOP1, EOP2, pre-NDA/pre-BLA)
  • Type C meetings are those not covered under Type A or Type B
  • Type D meetings are focused on a narrow set of issues (no more than 2 topics)

Step 2
When would you like to meet with FDA? Enter the desired date.

Step 3
Click CALCULATE to get your answer.

To start over or change your inputs, click RESET.

Need more information? See Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry.

STEP 1 – What kind of meeting do you need?

Type A Type B Type B EOP Type C Type D

step 2

reset calculate

OUTPUT

Build Meeting Request and Package
Date to submit meeting request to FDA Review Division:
Date FDA can be expected to respond to the meeting request.
Note that response could be a meeting date or the date for receipt of a “written response only” (WRO).
Meeting Package due to FDA Review Division:
Meeting date or date WRO can be expected:
Date FDA meeting minutes can be expected, if meeting Is held. (Not applicable to WRO.)
Questions?

If you have further questions regarding scheduling or preparing for your meetings with FDA, complete and submit the form below.

CONTACT US

Ask us anything.

We would be delighted to hear from you and discuss our consulting services. Please call +1 215 648 1208 to chat with us directly. Or write to us using the form provided here. We look forward to collaborating with you.