1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Regulation

First EUA In US For OTC Test To Detect COVID-19, Flu, RSV Granted To Labcorp

 
• By Brian Bossetta

Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.

Labcorp Logo
• Source: Shutterstock

The US Food and Drug Administration has granted an emergency use authorization to Laboratory Corporation of America (Labcorp) for its Seasonal Respiratory Virus RT-PCR DTC test for people with COVID-19 symptoms. It can be purchased OTC online or in stores.

Labcorp’s test which received an EUA on 16 May is the first direct-to-consumer diagnostic the FDA has authorized that allows for the collection of at-home nasal swabs that can identify...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

‘We Must Have The Truth’ – Calls For UWWTD Review Intensify As Evidence Looks ‘Shaky’

 
• By David Ridley

The evidence underpinning the “polluter pays” principle of the revised Urban Wastewater Treatment Directive - which calls on Europe's pharmaceutical industry to cough up at least 80% of the cost of updating wastewater treatment facilities - is looking increasingly shaky, according to a new report.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Policy & Regulation

Haleon Study: Boosting Health Literacy Could Save Major Economies Over $300bn Per Year

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.