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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

UK FSA Issues New Guidelines For CBD And THC Max Levels

 
• By David Ridley

Based on advice from its advisory committees, the UK's Food Standards Agency is encouraging businesses to meet an acceptable daily intake of 10mg CBD per day and a safe upper limit of 0.07mg THC per day.

Scope Launches Eyelid-Friendly Eye Cream In The UK

 
• By David Ridley

Eyelids have the "thinnest, most sensitive skin on the body" and are "highly prone to dehydration," which is why Scope has launched new Optase Life Sensitive Eye Daily Renewal Cream.

Get To Know: UK Women’s Wellness Start-Up GP Nutrition

 
• By David Ridley

Meet UK women's health start-up GP Nutrition, run by busy working mother of four Gabriela Peacock, who says she "truly understands the needs of the women who are looking to her for help.”