I read, however, a release by a company about its product under development that stated in the headline that the company was seeking a "Type B" meeting with the FDA. I felt kinda dumb because I didn't know what a Type B meeting was. (So… that is the interesting part.)
I had never even heard of it. But the fact that it was in a headline made me think that everyone else on the planet did know what a Type B meeting was. If you are one of those people, stop reading. If you aren't here is what it is (And… this is the boring part) but you might want to take a NoDoz.
There are apparently drawn up procedures that FDA has for medical product sponsors to request meetings with the FDA and there is even a Guidance issued that explains it all – "Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products". Obviously regulatory folks know all about this – but in case communications folks don't, here's the skinny:
There are three types of meetings, creatively named Type A, Type B and Type C.
- Type A Meeting – is a meeting that is "immediately necessary for an otherwise stalled drug development program to proceed." This type of meeting refers to meetings to resolve disputes, talk about clinical holds, special protocols. Think of them as a "Type A Personality" meetings. They should be scheduled within 30 days of the time that FDA gets a written request for a meeting.
- Type B Meeting – these are listed as (1) pre-IND meetings, (2) certain end of Phase I meetings, (3) end of Phase 2/pre-Phase 3 meetings and (4) pre-NDA/BLA meetings. The agency says they will always honor a request for these kind of meetings except where there are very unusual circumstances such as where inadequate data have been submitted. These meetings are generally scheduled within 60 days of the written request.
- Type C Meeting – can you guess? Yes, a Type C meeting is any other kind of meeting. These are scheduled within 75 days of request.
There are also procedures laid out in the Guidance, but since that part has really nothing to do with communications, I'm leaving that for you to read yourself if you are so inclined.
So I thought that was interesting (or not) just in case you ever came across a headline with the reference to a Type A or Type B or Type C meeting with the FDA. I wouldn't want you to be as flummoxed as I was.