The U.S. FDA has wrapped up an October 2015 draft guidance for animal studies for medical devices, which prompted some lengthy responses from stakeholders concerned about some unique terms, such as device “handling.” Despite industrial opposition to the inclusion of that term, the final guidance retains the term handling and defines it in part as the manner in which the device “responds to the demands of the operator,” a term that may or may not be encompassed by the FDA’s overarching policy for human factors engineering.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edap Tms, Icentia, Restor3d.
The long-running Makena saga came to a close April 6 with the U.S. FDA announcing its decision to immediately withdraw approval of the drug and its generics – the only drugs indicated in the U.S. to reduce the risk of preterm birth.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, AB Science, Accord, Advantage, Direct, Edesa, Inflarx, Mirum, Perfuse, Soligenix, Verismo.
The U.S. FDA has issued a guidance on when to file a new 510(k) for a class II device that has undergone significant modification, but that doesn’t mean everyone in the device business is paying attention. The FDA hit Synovo Production Inc., of Fullerton, Calif., for a number of violations of the Quality System Regulation (QSR), but also alleged that the manufacturer/specification developer made a number of modifications to its femoral resurfacing cup for hip implants without a new regulatory filing, leading the agency to direct the company to immediately cease production of the device.
The Biden administration has released the National Cancer Plan, a framework that expands and builds on the Cancer Moonshot program which came into being in 2016. The National Cancer Plan includes a strategies section that calls for development of new methods for detecting cancer and new imaging technologies for early cancer detection, just two provisions that would seem to portend good times ahead for companies that manufacture these products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abyrx, Synapse Biomedical, Zap Surgical.
As the number of drug shortages continues to grow in the U.S. and globally, the FDA is issuing a draft guidance spelling out drug and API manufacturers’ responsibility to give the agency a timely, informative heads-up about changes in their production that could lead to a shortage.
Despite an early stumble, the U.S. FDA granted emergency use authorization (EUA) to the C5a inhibitor Gohibic (vilobelimab) from Inflarx NV for treating COVID-19 in hospitalized adults. A year ago, an initial phase III analysis had failed to show a statistically significant effect on the primary endpoint of 28-day all-cause mortality though there was a relative reduction in mortality in the active arm vs. placebo.