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

US FDA Grants Three OTC Covid-19 Test EUAs Following Template Updates To Spur Development

 
• By Malcolm Spicer

Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes.

• Source: Alamy

The US Food and Drug Administration has authorized three OTC COVID-19 antigen diagnostic tests after providing templates to help developers provide necessary data and information in support of pre-emergency use authorization submissions.

The agency’s Center for Devices and Radiological Health on Nov. 22 announced emergency use authorizations for home-use COVID-19 antigen diagnostic...

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

IQVIA Consumer Health: Digestive Category Driving Global OTC Market Growth

 
• By David Ridley

An increasing awareness of and interest in gut health helped the global OTC market grow by 4.6% in value terms in 2024, according to IQVIA Consumer Health.

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

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."

More from Geography

Urban Wastewater Directive: AESGP Requests Intervention In EFPIA’s Legal Action

 
• By David Ridley

AESGP has formally submitted a request to the General Court of the European Union to intervene in the European Federation of Pharmaceutical Industries and Association’s legal action against the revised EU Urban Wastewater Directive.

Over The Counter: Seizing The Healthy Aging Opportunity, With Prime Fifty’s Max Gowland

 
• By David Ridley

HBW Insight speaks to Prime Fifty founder and managing director Max Gowland about the science behind healthy aging and the opportunity for the consumer health industry.

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.