Happy New Year everyone.
Usually by the end of the year, FDA publishes a tentative calendar for Advisory Committee meetings to be held for the upcoming year, however it appears that the calendar was just published today in the Federal Register and is reprinted below.
It is always interesting in what therapeutic areas the agency anticipates that it will be reviewing applications. In past years, the agency provided more specific dates than was provided this year where there are a number left “TBD”. However it appears that the committee with the most meetings will likely be the Oncologic Drugs Advisory Committee, consistent with years past on the CDER side, while on the CBER side Vaccines and the Celluar Tissue and Gene Therapies AdComms appear to have the most activity. Naturally FDA cannot say with certainty at this point how many meetings or precisely in what areas advisory committees will be meeting, but this provides a little insight into what they are anticipating.
Here is how CBER and CDER stacked up: