While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.
As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biohit, Cardiac Dimensions, Detectachem, Exsomed, Pq Bypass, Tissue Regeneration Technologies.
As 2020 approaches its last quarter, scientists around the globe continue their all-consuming efforts to find effective therapeutics and vaccines to fight the deadly COVID-19 pandemic, which currently has a 3.35% fatality rate and has been plaguing the world for more than half a year. While the fight rages on, people are growing weary of political posturing and community debates. They face a serious conundrum of how to best protect those vulnerable to the virus, while still considering the psychological and economic impacts of societal lockdowns.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: The American Medical Association, Obelisk Ventures, Philips, Quest Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ctl Amedica, Medtronic, Roche, T2 Biosystems, Transmed7.
