FDA Watch

Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit

Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test … [Read more...]

FDA Watch

Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]

FDA

Neutralizing Antibodies Detection Test for COVID-19 Gets the FDA Greenlight

Innovative new COVID-19 tests continue to emerge from the pipeline. One of the products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody Detection Kit from … [Read more...]

FOCUS ON

The Year in Labs Regulation: The 9 Biggest Stories of 2020

When 2020 started, COVID-19 was just a news story unfolding on the other side of the globe in China. The novelty of the pathogen meant that there were no tests specifically targeting the virus on the … [Read more...]

FDA Watch

Lucira Health Secures First EUA for Fully At-Home COVID-19 Testing Kit

Although the FDA has previously authorized COVID-19 diagnostic tests for at-home sample collection, it had never before granted Emergency Use Authorization (EUA) for an all-in-one diagnostic kit that … [Read more...]

FDA Watch

Agency Authorizes First Fully At-Home COVID-19 Testing Kit

With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people … [Read more...]

Industry Buzz

HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast

The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review … [Read more...]

The Business of Testing

HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19

Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]

FOCUS ON

What a Biden Administration Might Portend for Regulation of Laboratory Developed Tests

The roller coaster that has become FDA regulation of laboratory developed tests (LDTs) is about to get even more topsy-turvy now that Joseph Biden has been elected President of the United States. … [Read more...]

FDA Watch

Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV … [Read more...]


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