In my post of May 3rd (here), I raised a concern about the number of approvals posted in the month of April 2022 and the fact that there were quite a few days in April where there were no or few approvals posted. I followed up with the FDA Press Office to see what was going on, as, in the past, there have been instances when approval postings were derailed because of a computer systems problem. Well, I just heard back from them, and they acknowledged that there was an issue with one of the systems. Perhaps that explains the low number of approvals posted in April – as of today at 7:38 AM Pacific time, April’s postings showed 37 approval actions and 5 tentative approval actions for an unofficial total of only 42 approval actions for the month.
We will have to wait for the FDA’s official numbers to post before we have a real concern. The good news is that May approvals seem to be getting posted and through May 6 posting there are 11 Approval actions.