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 […]
Well, the first month of FY 2022 appears to be an improvement over the last month of FY 2021, which was reported as forty-nine total approval actions, as the OGD hit an unofficial total of sixty-two in October 2021. The total is broken down into fifty full-approval actions and twelve tentative-approval actions. Usually, a few additional […]
Well, September saw not only a low for this fiscal year (FY) of forty‑two total approval actions (both full (thirty‑nine) and tentative (three) approvals), but you have to go all the way back to February 2018 to find a lower number of total approval actions (thirty-seven). And, remember, that number was caused by the approval […]
The FDA has updated its first-generic approvals list for calendar year 2021 (here). The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals. As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]
As of the posting on September 3, 2021, the FDA’s “All Approvals” database (here) listed fifty-five full‑approval actions and eight tentative-approval actions for August. While we know that these numbers can creep up with a couple of stragglers being reported a bit late, the good news is that the OGD hit a total of at […]
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 […]
Happy July 9th! Hope you had a great Fourth of July weekend, but now it’s time to get back to business. The OGD seems to have squeaked by its lowest month totals of approval actions this FY (for May) as it appears to have recorded sixty total-approval actions for June, at least through the July […]
Overnight, the FDA posted its official approval numbers for May 2021 and the picture is not great. We reported in a previous blog post (here) unofficial totals of full-approval actions at forty-five and tentative‑approval actions at thirteen. We missed by one on each as the official numbers revealed forty‑six full‑approval actions and twelve tentative-approval actions […]
In Southern California, May is noted as a month that sees a usual marine layer hanging over the coast. They call it “May Gray”. June is not much better and has the adopted the moniker of “June Gloom”. We often get sunshine later in the day, but most mornings are a combination of low clouds […]
Well, our unofficial projections got the full approval actions right (at 55) but we missed one tentative approval action that was posted late (we reported 16) (here) but the official total reported here actually tallied 17 for a total of 72 approval actions for April 2021. 11 of the 55 full approvals were for first-time […]
