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Question 13 of 20 Intermediate Practical

How would you prepare for a Type B meeting with FDA?

Short answer

Decide what decisions you need from FDA, write specific questions each with your proposed position and supporting data, and send a meeting package in time for review. Under PDUFA VII, FDA responds to a Type B request within 21 days and aims to hold the meeting within 60 days of the request.

Why

Type B meetings include pre-IND and pre-NDA or pre-BLA meetings, with end of phase 2 meetings as a separate Type B(EOP) category. The PDUFA VII commitment letter, covering fiscal years 2023 to 2027, sets FDA's goals: reply to a Type B request within 21 calendar days and schedule the meeting or send written responses within 60 days. For pre-IND meetings, FDA may decide that written responses only are enough.

The most common failure is vague questions. 'Does FDA agree the nonclinical package is adequate?' invites a vague answer. 'Does FDA agree that a 28 day rat and dog toxicology study with these doses supports a phase 1 starting dose of 10 mg?' gets a usable one. Each question should state the sponsor's position and the data behind it. FDA usually sends preliminary comments before the meeting, which lets the team decide which questions still need discussion.

Minutes are the record, so the sponsor should check them carefully. Agreement in a meeting is advice, not a binding decision, and can change if new data appear.

How to work it through

  1. List the development decisions that depend on FDA's view.
  2. Turn each into a specific question with the sponsor's proposed position.
  3. Assemble the briefing package with only the data needed to answer those questions.
  4. Submit the request and package within the timelines the agency expects.
  5. Rehearse responses to likely pushback and agree who speaks for each topic.
  6. Review FDA's preliminary comments, decide what still needs discussion, and check the minutes afterwards.

An example

A biotech plans a pre-IND meeting for a monoclonal antibody. It writes 6 questions: starting dose, toxicology species, need for a reproductive toxicity study before phase 1, potency assay strategy, first in human design and sentinel dosing. FDA grants the request in 18 days and sends written responses on day 58.

FDA agrees with 4 positions and asks for a tissue cross reactivity study and a lower starting dose. The team updates its IND timeline by 6 weeks rather than learning this from a clinical hold.

Where the answer stops holding

Meeting goals are performance targets, not guarantees, and FDA can convert a meeting to written responses only. Advice reflects the data presented, so it may change with new findings. PDUFA VII runs to fiscal year 2027, and the next agreement may change meeting types or timelines.

A strong answer covers

  • Specific questions with sponsor positions
  • Type B timelines: 21 day response, 60 day meeting
  • Focused briefing package
  • Use of preliminary comments
  • Minutes as the record and advice as nonbinding

Common mistakes

  • Asking open questions that cannot be answered yes or no.
  • Overloading the package with data unrelated to the questions.
  • Treating meeting agreement as a binding commitment from FDA.