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

US FDA Updates Template For OTC COVID-19 Test Development

 
• By Brian Bossetta

The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.

Woman Taking At Home Test
• Source: Alamy

The US Food and Drug Administration updated a template used to help developers provide the necessary data and information in support of a pre-emergency use authorization (EUA) submission for OTC home-use molecular or antigen diagnostic COVID-19 tests.

The “Molecular and Antigen Home Use Test Template” now includes “updated recommendations and additional clarity for test developers,” the FDA said on 9 November. The updated template also includes...

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

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

‘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.

More from Policy & Regulation

Loper Bright ‘Might Not Be Cataclysmic’ With FDA’s ‘Good Reputation’ For Science – Attorney

 
• By Malcolm Spicer

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.

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.

Self-Care Must Be Central To NHS Reform, Says UK Industry And Pharmacy Alliance

 
• By David Ridley

Ahead of a soon to be released 10-Year Health Plan for the English NHS, an alliance including PAGB calls for self-care to be “clearly recognised and supported through concrete policies that reflect its vital role in achieving the plan’s goals.”