The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing.
LONDON – The SARS-CoV-2 variant of concern that caused a wave of infection in Manaus, Brazil, in December and January has been found to be both more transmissible and to evade immunity conferred by prior natural infection with the virus.
With several more emergency use authorizations (EUAs) across the globe, COVID-19 efforts to flatten the emerging variants with cocktail therapies and tweaked vaccines are frantically underway. BioWorld has tracked 884 therapeutics and vaccines that have entered development for the deadly SARS-CoV-2 virus since it first emerged more than a year ago, and the U.S. government has now provided EUAs to three vaccines and six therapies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Argenx, Astrazeneca, Beigene, Biocryst, Biogen, Eisai, Eyenovia, Fibrogen, Merck, Molecular Targeting Technologies, Oyster Point, RDIF, Sorrento, Strongbridge.
Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CRS: Supply chain for testing still under pressure; AHRQ eyes provider-to-provider telehealth; Health Canada emphasizes nursing homes in report on testing; Advamed, Georgia Bio sound off on EtO.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Fluidigm, Invo Bioscience, Memic Innovative Surgery, Mobidiag, Opgen, Perimeter Medical Imaging AI, Vascular Grafts Solutions, Vetex Medical.
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