While not down by much, the unofficial approval numbers are down yet again.  The previous low for a month this FY was 58 (both full [46] and tentative [12] approvals). July saw only 56 (47 full and 9 tentative approvals).  This is the third month in a row where the numbers have been well below the average monthly approval totals of 74 for all approval actions.  The full approval action monthly average through 9 months was 59.9 and the tentative approval action monthly average is 14.4.  Now, remember, these are unofficial because OGD has not yet published its official number for July, but it is likely very close.

While I hope this does not become the new norm, it is looking more like a trend that I am certain industry will not be excited about.  We will report more on the projections for the year when the official OGD numbers come out for all metrics in a few weeks.  You can view the July approval actions at the FDA’s All Approval list here  .  Make sure you search on July.