In December, the third month of FY 2026, the number of unofficial approval actions fell significantly from those in the first two months, with the OGD issuing 41 full-approval actions and 13 tentative-approval actions for a total of 54. * December numbers are unofficial but should be close to final. The reasons are not obvious as […]
The FDA reports 27 full-approval actions and 9 tentative-approval actions through December 17, 2025 as posted on its daily (here) and all approvals (here) pages. This total of 36 full- and tentative-approval actions appears to be on the average side and, with the holiday coming up and the number of employees likely absent for vacation, it […]
November 2025 output picked up as the OGD issued 59 full-approval actions and 25 tentative-approval actions in the month. The total of 84 approval actions is the highest since June 2025 when the OGD issued 89 approval actions. It’s also an improvement over October 2025’s output of 75, the first month of the new fiscal […]
We’ve been waiting for the first Generic Drugs Program Monthly and Quarterly Activities Report to be published for FY 2026, and it arrived sooner than expected! There’s at least one surprise and there are a few other interesting observations that we will discuss regarding new ANDA submissions for October 2025. But first, let’s talk about approvals. […]
On November 24, 2025, the FDA announced (here) that, following a comprehensive safety review, it has approved a reformulated ranitidine tablet, “marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during […]
Don’t blink – things can change in a minute, or at least in one day. After our blog post yesterday on mid-month approval actions for the OGD, a flurry of activity occurred in the postings from a few days past. The new mid-month approval actions can now be reported as 38 full-approval actions (that’s 12 […]
There are two federal holidays, Veterans Day and Thanksgiving, in November, making it a crazy month. Lots of Agency staff take vacation around the two holidays, and Thanksgiving week is particularly laden with staff vacation days, which is little surprise as it is one of the busiest travel times for everyone in the U.S. Despite […]
From a historical perspective, I can’t remember when the turmoil at the FDA was greater, nor can I remember when the morale was lower with perhaps the exception of while the generic drug scandal of the late 80s was occurring. However, despite all the turmoil and the distractions, the Office of Generic Drugs (OGD) has […]
As I was sitting at the AAM’s GRx-Biosims meeting this week listening to the presentation from Dr. Iilun Murphy, Director of the Office of Generic Drugs, I clicked on a link on my computer for the Generic Drugs Program Monthly and Quarterly Activities Report and noticed that the report had been just updated with the […]
Elizabeth Miller, Associate Commissioner for Inspections and Investigations, provided an update on the FDA’s Office of Inspections and Investigations (OII). She noted that the government shutdown has impacted the OII’s core activities which include inspections, investigations and imports. She noted that the lapse in appropriations has resulted in the need for risk-based prioritization of OII’s […]
