In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]
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 […]
The must pass User Fee Reauthorization Bill has a lot of amendments tacked on and provisions are starting to come into focus. But remember- the final Bill mark-up by the House and the Senate will be the only time we will know for sure what’s in and what’s out. As of today, it appears that […]
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 […]
Now, HERE is a Q&A document that makes the how, who, why, and when very clear. This Q&A final guidance outlines responses to a question that the Agency has fielded since the final rule regarding importation of prescription drugs went into effect on November 30, 2020. Of importance, this rule does not cover individual personal […]
You may need some time to read this recently published guidance entitled, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (here), as it is 41 pages long. There is lots of good information contained in the document and, while it may contain most of what you know about labeling requirements, […]
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 […]
