FDA Eager To Authorize More Rapid Antigen COVID-19 Tests
The US FDA’s diagnostics chief says the agency isn’t seeing many submissions for rapid antigen tests, but is eager to authorize them.
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An alert from the agency warns that the tests, which have become widely used for their speed and portability, carry a risk of false positives.
Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.
The US FDA commissioner published a blog post commending and highlighting the work device center staff have done during the pandemic to speed tests and devices to market to save lives.