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 […]
Well, with the only reported number that is up this month being for the receipt of new ANDAs (seventy‑six, the third highest number of new ANDA submissions in a month thus far this FY), I think we have some head‑scratching to do. Should the current rate of new ANDA submissions continue in the fourth quarter, […]
“Surprise” seems to be the best word to describe the updated May statistics report regarding the issuance of refuse-to-receive actions (RTR), which was reported as eleven (eight for standard ANDAs and three for priority ANDA submissions). It has not been since June 2018 that so many RTRs were issued. There is no telling whether this […]
The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]
As the OGD has reported the official approval numbers for March, let us note that we projected the actual number (63) in our unofficial count (here) in our April 5th post. Please realize that this month (March) included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change […]
The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics. As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]
