With half of April in the books, the number of OGD approval actions posted as of April 14th includes twenty‑seven full‑approval actions and four tentative‑approval actions for a total of thirty‑one approval actions. It looks like the OGD is heading towards an average approval month for April. Average definitely isn’t a bad thing, especially since the unofficial approval numbers for March, which we posted here, look pretty good. (Please note that we’re still waiting for the OGD’s official March numbers to be posted.) Once the FDA posts these official numbers, we will summarize the first six months of FY 2023 for our readers and make some projections for the full fiscal year. The delay in posting the March approval figures may be due to the need to gather the mean and median approval times for the end of the second quarter. That task appears to slow down the posting of all of the metrics, but these are important metrics for the industry so they’re worth the wait.
18
Apr