Regulatory glossary

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

FDA sorts formal meetings with drug and biologic sponsors into four types. The type determines how quickly FDA responds, so choosing it is a scheduling decision before it is anything else.

Type A

For a programme 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.

The fastest clock, because by definition nothing is moving until it happens.

Type B

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

These are the meetings where the shape of your programme gets agreed. The end-of-phase-2 meeting in particular is where the pivotal trial design either gets FDA's agreement or does not, and finding out afterwards is the expensive version.

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.

Longest clock at 75 days, which is why a Type C requested late is often a Type C answered after you needed it.

Type D

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

The trade is scope for speed. If your question list grows during preparation, FDA can reclassify it, and a Type D that becomes a Type C loses the timing advantage you chose it for.

Also worth knowing: INTERACT meetings, for early advice on novel products before the pre-IND stage, are treated as a formal meeting type under the same guidance rather than an informal chat.

The meeting package is the meeting

This is the part sponsors underestimate.

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 is not preparation for the conversation. It frequently is the conversation.

What that means practically:

• 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 programme?"
• 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. Ten questions produces ten short answers. Four well-framed ones produce four 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.

Where meeting requests go wrong

• 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.