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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Syntheticmr.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeon, Cytodyn, Innovent, Nippon Shinyaku.
The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.
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.
Tissue Regeneration Technologies LLC (TRT) has nabbed U.S. FDA 510(k) clearance of its Orthogold 100 device for the treatment of superficial burns. The patented Softwave technology uses an unfocused extracorporeal shock wave to spur a physical and biological response that aids in wound healing. The FDA cleared the device for the treatment of superficial, partial-thickness, second-degree burns in adults.
In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
It turns out that determining who gets a COVID-19 vaccine first can be nearly as challenging as developing the vaccine itself. The timeline is a big part of the challenge.
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