The first month of the new FY was (unfortunately) a slow start out of the gate. While not the lowest month we have seen over the past year, it is certainly at the lower end of approval actions. In October, OGD issued 43 full approval actions and 8 tentative approval actions. It was interesting that […]
There were a few new and some old things mentioned in the post approval session and here are a few nuggets that may be helpful for our readers to know. With regards to CBE-0 and CBE-30 supplements, there is a new process that OGD will use. This new process was developed to better trace these […]
The CDER and CBER call a prospective written plan to assess and manage post-approval chemistry, manufacturing, and controls (CMC) changes a Comparability Protocol (CP). These protocols are typically submitted in the original market application and, if the CP is approved, it allows firms to make certain changes outlined in the protocol without further FDA approval. […]
Yesterday, the FDA provided the 2027 science and research initiatives which were determined in collaboration with industry and the public, including feedback received during the FY 2026 Generic Drug Science and Research Initiatives Public Workshop. Each year through the GDUFA program, FDA identifies areas of research that address important and challenging scientific issues for “critical […]
The newly released FDA Guidance “Regulatory Considerations for Prescription Drug Use – Related Software Guidance for Industry” reflects a formal convergence of labeling and prescription drug use-related software. This guidance, which was originally published in 2023 as a draft guidance, has now been finalized by FDA. Digital interactions are becoming an increasingly integral part of […]
This morning, I was perusing the agenda for the upcoming GRx-Biosims 2026 conference and was reviewing the list of speakers when I noticed that Darby Kozak, Ph.D., was listed as the Acting Director of OGD. I searched the FDA’s OGD webpage, and lo and behold Dr. Iilun Murphy was still listed as the OGD Director. […]
With the official August 2026 numbers reported, let’s take a walk on the wild side and try to predict what the full FY 2026 ANDA approval numbers may look like as we won’t see the full FY 2026 official report on approved ANDAs until sometime in November. Data from the FY 2026 Generic Drugs Program […]
While not yet available in pharmacies, Onswik (insulin efsitora alfa-gobe) injection for subcutaneous use was approved by FDA on September 23, 2026. So, what’s new? This is a once weekly injectable insulin (instructed to be injected on the same day of the week), which according to the Lilly webpage here (and also by my own […]
CDER published a study titled “First-Cycle Complete Response Rates for CDER NDA and BLA Applications” (here). I read and reread it a few times and I am still confused. It appears that FDA published this report to counter industry’s stated belief that the number of Complete Response Letters (CR) have increased over time. This is […]
Just like the new season of Slow Horses premiering in September on Apple TV, it appears that September is also starting out to be a “slow” approvals action month at OGD. With this being midway through the last month of FY 2026, thus far through September 15th, OGD posted only 17 full approval actions and […]
