FDA Meeting Types: A, B, C and D, Explained

FDA sorts formal meetings with drug and biologic sponsors into four types, and the type sets how quickly FDA responds.

Type A

For a program that has stopped and needs FDA's help to restart. Dispute resolution, a clinical hold, a meeting after a Complete Response Letter, or a special protocol assessment disagreement.

It has the fastest clock because the program cannot proceed until it happens.

Type B

The milestone meetings that structure a development program: pre-IND, end-of-phase-1 for certain products, end-of-phase-2 or pre-phase-3, and pre-NDA or pre-BLA.

The end-of-phase-2 meeting is where FDA agrees or disagrees with the pivotal trial design, before you have paid for the trial.

Type C

The catch-all: any formal meeting that is neither A nor B. Often used for CMC questions, for a discussion of a proposed development approach mid-phase, or for questions about a specific study that does not sit at a milestone.

At 75 days it has the longest clock, so request it early.

Type D

The newest category, introduced under PDUFA VII. It is for a narrow question: typically no more than two focused topics, needing input from no more than about three FDA disciplines, with a 50-day response.

If your question list grows during preparation, FDA can reclassify the request as Type C and the 50-day timing is lost.

INTERACT meetings, for early advice on novel products before the pre-IND stage, are a formal meeting type under the same guidance.

The meeting package

FDA reviews your package and, for many meetings, sends written responses before or instead of a live discussion. Where written responses answer the questions, the meeting may not happen at all, so the package has to work as the whole exchange.

• Ask answerable questions. "Does FDA agree that the proposed design is adequate to support approval?" gets a more useful answer than "What are FDA's thoughts on our program?"
• Give the background the answer needs. A question FDA cannot answer without data you did not include comes back as a request for that data.
• Limit the question count. A long list gets short answers; a few well-framed questions get useful ones.
• State your position. Asking FDA to agree with a stated position is more productive than asking an open question, because disagreement then tells you something specific.

Common mistakes in meeting requests

• Wrong type chosen for speed. Requesting Type D for a broad set of questions invites reclassification and a longer wait than asking correctly.
• Requested too late. Work back from when you need the answer, adding the response window plus your own time to act on it.
• Questions that are really one question. Sub-parts of a single issue presented as separate questions inflate the package without adding clarity.
• Ignoring prior commitments. FDA has the record of what you said before. A question that contradicts a previous commitment gets answered by pointing at it.
• No plan for a written response. If FDA answers in writing and cancels the meeting, the package has to have been complete enough for that to be a good outcome.