The Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the first quarter of FY 2022 (here) has both good news and bad news. The proverbial question is, which one do you want first? At this juncture, I might also point out that some of the data is also difficult to […]
We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions. We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two. Thus, the total number of approval actions […]
While it has been over a full month waiting for official approval numbers, receipts and complete response statistics for November of FY 2022 to post, and after bemoaning the delay in one of posts yesterday, they popped up either overnight or early this morning. The full approval actions hit 67 (we unofficially missed by one […]
December of FY 2021 sure didn’t break any records as the OGD managed to eke out only 34 full‑approval actions and 13 tentative‑approval actions. We would have to go all the way back to February 2018 to find a lower full‑approvals total for a month, and the total for that month was 32. The tentative‑approval […]
The OGD updated its statistics for the first month of the fiscal year but here we are on December 23 and the usual November early stats for approvals, Complete Response Letters, and new ANDA submissions have not yet posted. Anyway, back to the October updated statistics. There were 3 refuse-to-file (RTR) letters issued to start […]
Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions. November has at least […]
On Friday afternoon, the OGD posted the remainder of the metrics for the last month of FY 2021. While we know what the approval statistics were for the full year, along with the comparisons for previous FYs since the inception of GDUFA (see previous blog post here), there are other interesting metrics that need to […]
Overnight, FDA updated its metrics for August and also provided some critical metrics to end out FY 2021 (here). Let’s take a look at the August update first. OGD issued three (3) Refuse-to-Receive letters in August, which appears to be consistent with the numbers for the year (with the exception of 11 RTRs that were […]
There is a baking show on Netflix called “Nailed It.” The show is a riot, and its premise is based on amateur bakers trying to copy a creation baked by a famous pastry chef. The amateur baker that comes closest gets a trophy that says, “Nailed It,” even though (in reality) their end-product may look nothing like the professional’s version. Anyway, as far as the approval-action predictions we issued […]
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 […]
