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 […]
As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]
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 […]
In its “FDA Roundup: February 4, 2022,” the FDA announced that “on Feb. 2, the FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country.” The FDA says that it will continue to conduct mission‑critical foreign and domestic […]
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 […]
Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference. This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]
According to Zachary Brennan of Endpoints News (see here), the FDA announced yesterday that it will hit the pause button again on upcoming routine domestic inspections due to the COVID-19 Omicron variant’s rapid spread. The initial pause will be for two weeks, but, depending on the state of knowledge about the status of the Omicron […]
The FDA’s Center for Devices and Radiological Health issued two guidance documents to address the transition plans for device EUAs issued during the COVID-19 public health emergency (PHE). The first guidance is titled Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and the companion […]
