With just about half of the month gone, and given that there have already been two holidays in January, the reported number of full-approval and tentative-approval actions looks pretty promising. Through January 17th at 9 a.m. Eastern time, the OGD has listed twenty-eight full-approval actions and ten tentative-approval actions in the All Approvals database for a total […]
Well, as we predicted in an earlier post in December (here), it was postulated that the month would not be a great month for approval actions. However, OGD did issue 25 approval actions in the last nine business days of December and ended the month unofficially with 52 full approval actions and 7 tentative approval […]
As of November 16, 2022, the OGD has published the issuance of thirty‑three full‑approval actions and four tentative‑approval actions. With Thanksgiving around the corner and the predictable number of staff off on PTO, the back‑end of November might not be as productive as the first half. We will keep an eye out and post an […]
October is the first month of the fiscal year 2023 and, while not necessarily a bellwether of things to come, it is certainly the starting point of GDUFA III. The unofficial tally looks good as OGD issued 58 full approval actions and 11 tentative approval action for a total of 69 total approval actions. While […]
As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”. The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news. First, the number of ANDA awaiting FDA action […]
This is the first month of GDUFA III and thus the first month of FY 2023! For approval actions posting through October 19th which include approvals posting through October 17th (postings are usually one or two days behind the actions taken), OGD has issued 22 full approval actions and 6 tentative approval actions for a […]
Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th. Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately. […]
Well, OGD has snuck in one additional full approval and one additional tentative approval from the unofficial numbers we reported on September 6th (here). So, in actuality, FDA full approval actions for August were 75 and tentative approval actions were 22 for a whopping total of 97 (2 more than we found in available public […]
July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions. In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here). That darn additional TA was posted after our blog post (so close!). So, the OGD hit over the seventy‑mark again […]
With a flurry of approvals at the end of the month, the unofficial count of approval actions for July 2022 breaks out as follows: 65 full approval actions and 12 tentative approval actions, for a total of 77 approval actions. This is the 7th out of 10 months that the total approval actions have broken […]
