Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robotica, Sofwave.
Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
At first glance, the U.S. FDA’s draft guidance for evidentiary expectations for 510(k) implants seems to demand more rigor on these applications, but some in industry believe that several of these elevated requirements offer little or no commensurate benefit. Geeta Pamidimukkala of the Advanced Medical Technology Association (Advamed) said the draft would seem to require that manufacturers preemptively explain the exclusion of animal testing, a requirement she said creates more work for both industry and FDA without offering a meaningful benefit.
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CGBio, Endosound, Pulnovo.
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
In his latest effort to boost the U.S. manufacturing base, President Joe Biden is invoking the Defense Production Act (DPA) to expand the domestic production capabilities for essential medicines, medical countermeasures (MCMs) and their critical inputs.
Nearing the end of 2023, South Korea’s National Assembly approved hiked-up budgets for three of its major health care agencies. Its health policy think tank also forecast an uptick in industry exports in 2024.
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.
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