First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]
Once again, with October approval action postings surprisingly low, I confirmed that the FDA is still having trouble with its internal IT systems that generate this information and populate certain databases. While it does not appear to be impacting data regarding NDAs, the ANDA postings are spotty at best. The word came back from OGD […]
August was an even better month than we predicted in our post on September 8th (here). There were actually 98 (instead of 96) full approval actions and 12 tentative approval actions for a total of 110 approval actions. The two (2) approvals missed likely were at the end of the month when we first discovered […]
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 […]
