FDA approval actions listed through December 15th include only seventeen full‑approval actions and six tentative‑approval actions for a total of twenty‑three total approval actions. As it stands, if these numbers represent one half of a month, it would mean that, at the current pace, we would see forty‑six total approval actions for the month of December. You have to go all the way back to FY 2015 to find lower December numbers (thirty‑five total approval actions).
December is not the best month for approvals because of FDA staff vacations around the holidays, but it has held its own since 2015 as having either an average or above‑average total compared to other months. Hopefully we will see the approval actions pick up as the month moves forward. We will report further towards the end of the month to keep you updated on the approval‑actions outlook for this month.