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.

Questions?

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

How to use this tool

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

  • 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)
  • INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDERProducTs) meetings are intended for novel questions andunique challenges in early development (i.e., prior to filing of an IND)

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.

Or download your own copy of our FDA Meeting Checklist here.

 

STEP 1 – What kind of meeting do you need?

Type A Type B Type B EOP Type C Type D INTERACT

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 request 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.)
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