The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Motus GI, Sml Genetree.
As the world begins to emerge from a horrific pandemic, armed with high-efficacy vaccines and a roadmap of lessons learned, it has become abundantly clear that dangerous infections are here to stay, and it is up to health care leaders and citizens to remain prepared and vigilant in preventing another deadly and disruptive COVID-19. During the last day of the virtual 39th Annual J.P. Morgan Healthcare Conference, two health care leaders discussed the efforts and mistakes experienced, as well as the path forward toward herd immunity and the unknown outbreaks to come.
LONDON – A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections. Now is the critical time to do this, as the level of both natural and vaccine-conferred immunity that might drive natural selection is increasing, said Wendy Barclay, head of the department of infectious disease at Imperial College London, who is leading the G2P-UK (Genotype to Phenotype-UK) project.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, DBV, Gracell, Pfizer, RDIF, Steba.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum.
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