1. HBW Insight
  2. >>Geography
  3. >>International

Premarket Review Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic

 
• By Malcolm Spicer

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

• Source: Shutterstock

The first OTC COVID-19 test authorized through the Food and Drug Administration’s premarket review pathway, not on an emergency waiver, also is the first at-home test for any respiratory illness the agency authorized using its traditional evaluation process.

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 International

Stada Expands Oilatum Range To Meet Saudi Arabia’s Skin-Care Needs

 
• By David Ridley

Stada launches nine new Oilatum products in Saudi Arabia including “rich moisturising creams for intense hydration, gentle body washes for daily cleansing, and baby-specific products like soothing bath bubbles and head-to-toe wash.”

Bayer And GSCF Paper Outlines ‘Practical Actions’ For Scaling Self-Care Globally

 
• By David Ridley

Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."

UK Honors PAGB’s Riddalls And ISF’s Webber For Self-Care Service

 
• By David Ridley

PAGB CEO Michelle Riddalls and ISF president emeritus David Webber have been awarded OBEs for their services to consumer health and self-care.

People On The Move: Appointments At GSCF, MENAP-SCI, Clasado

 
• By Tom Gallen

A round-up of the latest consumer health industry appointments: GSCF names next director general, MENAP-SCI elects chairman; Clasado hires BD director.

More from Geography

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By David Ridley

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
• By David Ridley

HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.