The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Global Health Innovative Technology Fund, Health Canada, Therapeutic Goods Administration.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bioniz, Gan & Lee, Huyabio, Landos, Mitoimmune, Ortho Regenerative, Tarus.
The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Electrocore, Orthofix, Surgical Information Sciences, Vysioneer.
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