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The agency is allowing laboratories to use tests they develop and validate before the FDA has issued an EUA for their test but will also allow states to authorize tests in some situations. Read More
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