The US Food and Drug Administration published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on February 23, 2022. After four years in the works and much debate about what the PR would include, we can finally read it for ourselves. The question in my mind was […]
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 […]
In the prepublication edition of the Federal Register, the proposed rule on revisions to the Quality System Regulation was published today and may be found here. According to the notice, the Agency “is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with […]
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 […]
The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session. Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues. The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]
(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.) Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of […]
As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]
On February 2, 2022, I posted a blog on the Agency’s Guidance Agenda for 2022 (here) and chose seventeen of the ninety‑eight guidances listed that were my favorites for a number of reasons, but most of all due to what I felt was their significance. And, today, one of the guidances I had selected was […]
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 […]
January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days. Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]
