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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.

The FDA’s first premarket approval of an OTC test for any respiratory illness went to the first firm to receive...

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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

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
• By David Ridley

HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.

AESGP Annual Meeting: European OTC Market Outlook ‘Very Positive’ Thanks To Prevention Trend

 
• By David Ridley

The European OTC market grew at double the rate of the global market in the last twelve months, according to IQVIA Consumer Health, driven by a long-term trend for prevention. Consultancy Simon Kucher identifies a desire to live a longer, healthier life as the primary concern behind this trend.

AESGP Annual Meeting: Harmonizing EU VMS Max Levels Could Cost Sector Over €200m

 
• By David Ridley

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.