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 […]
The first month of the new fiscal year (FY 2026) appears to have gotten off to a slightly slower start than anticipated with the OGD reporting 23 full approval actions and 12 tentative approval actions. While there were 23 full approval actions, one of these represented a second strength of a previously approved product so it […]
Secretary Kennedy has basically accused much of the FDA and other parts of the HHS organization of being corrupt. One of his stated goals was to root out corruption. However, he never explicitly defined what the corruption was or identified any individual accused of it. Instead, he spoke of the revolving door where FDA employees […]
Today, the FDA posted its August 2025 monthly statistical report, and with FY 2025 ending on September 30, 2025, we’re only one update away from the official numbers for the full fiscal year. The August update indicates that the OGD did, as previously reported, fully approve 47 new ANDAs and (at OGD official count for the monthly […]
Well, it looks like the FY 2025 ANDA approval numbers are posted on the FDA full approval page but not yet in the official Generic Drugs Program Monthly and Quarterly Activities Report. Now, we may miss a couple here and there because the postings are sometimes slow, but I think this will give us a good […]
It has been a slow go for the first half of September, which is the last month of FY 2025. So far this month, there have been just 17 full-approval actions and 4 tentative-approval actions posted on the FDA daily approval page (here). This is the lowest number of approval actions midway through any month that […]
Here are some of the highlights of the recently issued Generic Drugs Program Monthly and Quarterly Activities Report for July 2025. For more details or to review the full report, please click here. Our analysis appears below. As we noted in a previous post (here), the OGD fully approved 52 ANDAs in July 2025, which […]
August was the slowest month for approval actions in FY 2025 and, now that we’re in September, let’s hope that this will not become a trend. The OGD issued 47 full-approval actions, the lowest of this fiscal year, with February the second lowest at 53. As far as tentative-approval actions, the OGD issued 14, also the […]
