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The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Rick Bright, the ex-director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), said that he was removed from his post because he pushed back against the administration’s promotion of two anti-malaria drugs to treat COVID-19. Read More
To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Read More
Congress last week allocated $25 billion to expand access to COVID-19 diagnostic tests as the FDA continues to pull out all the stops to get tests to the marketplace via Emergency Use Authorizations (EUAs) that exempt devicemakers from liability for product failures. Read More
The test uses a drop of blood to detect COVID-19 antibodies in approximately 10 minutes. It can detect both the presence of the virus and a patient’s potential antibody immunity to it. Read More
“Right now, we have no evidence that the use of a serologic test can show that an individual is immune or protected from reinfection,” the WHO official said. Read More