Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics. We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]
The FDA has updated its list of all ANDA final approvals for drug products that have received CGT designation. The list cites a total of 150 ANDAs and the first approval under the program dates back to August 8, 2018. So far in 2022, FDA has approved 29 such ANDAs, of which 10 have commenced […]
The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals. While not an all-time high for a single month, it is a welcome […]
There has been legislation introduced recently to change the provisions as to how the 180‑day award for being a first filer in a paragraph IV patent challenge works. The FDA has proposed some alternate changes as well, outlined in a current blog by our friend Kurt Karst (here). If you want your head to spin […]
Surprise, surprise! Just yesterday, we reported an anemic number of approvals through May 16th and today we were surprised to see (perhaps due to a fix to the FDA’s posting problem!) the new and now revised total through May 17th is thirty‑seven full‑approval actions (only one of which was approved on the 17th) and still one tentative […]
According to the reporting on the FDA’s Daily Approvals page and confirmed by the FDA’s All Approvals list at 9:45 AM, EST 5/18/22, there were a total of 15 full approval actions and one (1) tentative approval action so far in May. Could the glitch previously reported here still be a problem? We all hope […]
We can all sleep at night now, as OGD presented the official approval action numbers today (here) and the computer glitch that was reported earlier is in the rearview mirror (for now at least). The good news is that OGD reported a total of 62 approval actions (20 more than appear on the FDA’s All […]
In my post of May 3rd (here), I raised a concern about the number of approvals posted in the month of April 2022 and the fact that there were quite a few days in April where there were no or few approvals posted. I followed up with the FDA Press Office to see what was […]
Data integrity (DI) has been a problem for as long as I remember, and my memory goes way back. The first real exposure I had to DI issues dates to the early days of Hatch-Waxman, passage of which had led to the generic drug scandal of the late 1980s. I could write a book about all […]
In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting. As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting. The presenters reviewed the types of required and […]
