Through May 15, 2026, the OGD reports 26 full approval actions and 11 tentative approval actions. Given the number of actions in the first half of the month, May approval actions will likely fall well behind the April figures, even if the approval pace picks up. So, with 37 total approval actions thus far in May, we still could have a month with over 70 total approval actions, which would be in the monthly average range for FY 2026.
We know that there are up and down months and we can’t always expect a large NCE-1series of product approvals like that which occurred in April (some 29 approval actions on a single day) so we have to be cognizant of what we’ve come to know as the normal pace of approvals.
With the FDA in a renewed hiring mode, replacing a significant number of the positions (about 3,000) that were lost during the DOGE scourge, we can only hope that things at the Agency will get back on a more predictable and stable footing. The brain drain at the FDA and loss of institutional knowledge have created significant issues that impacted stability at the FDA and predictability for industry. Perhaps if those two factors can once again be relied upon, maybe some of the former senior FDA officials may consider rejoining the FDA family and other highly qualified personnel can be attracted to joining the Agency.
We’ll be back at the end of the month with some additional figures for you to chew on.
