In a twist that I am sure the FDA did not see coming, the landscape of FDA’s compounding position and the use of the Memorandum of Understanding (MOU) between the FDA and the States took a hit in a court decision back in “October 2020, [when] FDA was sued in the U.S. District Court for […]
The FDA is warning healthcare professionals of potential risks associated with compounded ketamine nasal spray (here). The Agency states that there is no approved ketamine nasal spray. Hey, wait a minute! (you might say); I could have sworn that I read about a ketamine nasal spray approval? Well, close! The product you may be thinking […]
As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]
Late Wednesday afternoon, the FDA posted official metrics for the items mentioned above. This was a p quick turnaround for these figures as they usually come out about the middle of the month. The OGD report (here) lists 61 full approval actions (we missed on our predictions by 1), which included 7 first generic approvals, […]
Sanitation Tunnels, as the name implies, are tunnels where a spray mist of antiseptic or disinfectant can be sprayed onto humans or animals. These tunnels, according to the FDA, were first employed in China and are being used in countries outside the United States to treat or prevent the spread of COVID‑19. The FDA further […]
Here we are in February 2022 and the FDA has updated the full report of statistical metrics for December 2021. Let’s take a look at some metrics of interest. We are three for three – for refuse‑to‑file (RTR) actions, that is. Each month in FY 2022, we have seen the OGD issue three RTR actions. […]
On January 31, 2022, CDER released its Guidance Agenda for new and revised guidances expected to publish in 2022. While the list is somewhat aspirational, it provides a window into what the Center is working on and what we might see this year. The document lists 98 new and revised guidance and can be found […]
FDA took action to fully approve Moderna’s Spikevax which had been the subject of an Emergency Use Authorization (EUA) since December 18, 2020. This means that the FDA has finalized its comprehensive review of the safety and efficacy of the Moderna vaccine. This is the second Covid-19 vaccine to gain full BLA approval status, the […]
Ozempic (semaglutide) is advertised on TV quite a bit. The jingle (identified in the title to this post) kind of sticks in your head. Ozempic is approved “for adults with type 2 diabetes used along with diet and exercise to improve blood sugar and lower A1C. It also lowers the risk of major cardiovascular (CV) events […]
With ANDA reporting through January 21, 2022, the OGD has issued thirty full‑approval actions and eight tentative‑approval actions for a total of thirty‑eight approval actions issued so far this month. With only six more reporting days remaining, these unofficial numbers, gathered from the FDA All Approvals list here, it looks like the total approval actions […]
