FDA seeks non-laboratory diagnostic tests, updates list of bad hand sanitizers

Jul 29, 2020 - 02:46 PM
FDA-guidance

The Food and Drug Administration today released a new template to help commercial developers submit emergency use authorization requests for COVID-19 diagnostic tests that can be performed in non-laboratory settings and available by prescription or over-the-counter.

“We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available,” said FDA Commissioner Stephen Hahn, M.D. “These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”

In other news, FDA yesterday issued emergency use authorizations to Eli Lilly and Sandia National Laboratories for molecular diagnostic tests for SARS-CoV-2. The agency also continues to warn health care providers and the public not to use hand sanitizers containing methanol. FDA has updated its do-not-use list of hand sanitizer products; in most cases, methanol does not appear on the product label.

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