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
April 20, 2020
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
April 7, 2020
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
March 30, 2020
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
March 19, 2020
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
March 17, 2020
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
March 17, 2020
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
January 30, 2020
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...]
