Just wanted to catch you up on a session related to generic drugs that I found particularly interesting presented by Edward “Ted” Sherwood, Director of Regulatory Operations, OGD, on some statistical metrics that are quite impressive. Among other things, the presentation outlined missed GDUFA goal dates, but was not inclusive of those misses for imminent […]
Well, folks, it looks like the FDA got its ANDA approval posting computer glitch fixed, but even that does not seem to guarantee good news. The FDA issued forty-one full-approval actions and ten tentative-approval actions for (an obviously low) total approval actions of fifty-one. That is the lowest number of full-approval actions since December of […]
The title of this blog was also the title of the presentation given by Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research. I just could not think of a better title! It is like the State of the Union address but not as expansive. Dr. Corrigan-Curay spoke to the […]
This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]
We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March […]
Over the Labor Day weekend, the FDA provided the latest full statistical report for the Office of Generic Drugs (here). The news continues to be good on the approvals front as the OGD issued sixty-nine full approval actions (one more than we captured in our unofficial peek (here) as the OGD snuck one by us). […]
Well summertime and its usual vacation schedule has not put a damper on ANDA approval actions and thus, I am happy to report that posting through August 16th reveal that OGD has issued 41 full approval actions and 7 tentative approval actions. If this pace keeps up for the rest of August, this will be […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023. There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023. OGD approved 76 new […]
After a slow start to the month, the steam is beginning to power up and halfway through July, OGD has issued 32 full approval and 9 tentative approval actions, so it looks like it should wind up being a good month if the last week’s proliferation of approvals continues. These figures represent postings of Approval […]
