Emerging Markets

After Early Skepticism, FDA Warms to At-Home Sample Collection for COVID-19 Testing

Even before the pandemic began, concerns over the marketing of fraudulent home testing kits had been a sore spot with the FDA. So, when the agency first began to roll out its liberalized clearance … [Read more...]

FDA Watch

Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time

The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has … [Read more...]

Emerging Tests

Inside the FDA’s Four-Armed COVID-19 Test Response Strategy

What started as the traditional Emergency Use Authorization (EUA) response deployed by the FDA for previous infectious illness outbreaks has rapidly evolved into something altogether different and … [Read more...]

Focus On

FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests

The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]

Coronavirus

FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests

The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]

Coronavirus

FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests

The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]

REIMBURSEMENT

Billing & Coding: CMS Sets Rules for Medicare Coronavirus Testing Reimbursement with Private Payors Expected to Follow Suit

Good news for labs that are testing Medicare patients for the SARS-CoV-2 virus that causes coronavirus using the Centers for Disease Control and Prevention (CDC) 2019 Real Time RT-PCR Diagnostic Test … [Read more...]

FDA Watch

Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]


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