Well, it was May gray, as reported in our previous post (here),as OGD full approval actions plummeted in May to just 45, the lowest this fiscal year and all the way back to June 2019. Tentative approval actions projections for May are 13, bringing the total approval actions for May to 58. That is the lowest total approval action total since February 2018.
Why the low numbers? Just a bad month? Maybe (as FDA has said some months will be good, and some will be not so good. Could it be inspection delays? FDA says ‘No’. We will be at a loss until we see the figures for the full month in terms of the other metrics FDA typically reports. We still do not have the update to the remaining April stats that FDA typically reports. Perhaps we will see higher than normal complete response letters, discipline review letters, information requests, and controlled correspondence intake all of which takes up available resources.
Lets hope June moves in the right direction.