The U.S. FDA granted an emergency use authorization (EUA) for Quest Diagnostics Inc.’s self-collection kit for COVID-19. The kit allows individuals to collect their own specimens at home or in a health care setting.
New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory.
Few would dispute that the best way to find innovative solutions to the COVID-19 pandemic is through industry, academia and government working together. BioWorld data indicate that more than 45% of the biopharma deals with nonprofit entities (bio/nonprofit) in 2020 are indeed focused on fighting the globally-disruptive SARS-CoV-2 virus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baibies, Letsgetchecked.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
RSS
