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US FDA Remains Concerned About OTC Access To COVID-19 Tests After It Allows First 'At-Home' Use

 
• By Malcolm Spicer

OTC access to any test to diagnose COVID-19 without supervision by a health care professional isn't on the near-term horizon for potential launches in the US. In addition to diagnostic kits, digital apps available to directly to consumers for COVID-19 testing on their own would face a steep climb to approval.

Riga, Latvia - April 8 2020: Coronavirus SARS-CoV-2 testing at home. COVID-19 Rapid test cassette for coronavirus. Man holding a rapid testing kits. Man reading a manual how to do a Test at home

Making available in the US "at-home" COVID-19 tests is getting as much attention lately as the virus itself, most recently with the announcement of an emergency use authorization of a serological test consumers can access through doctors' referrals.

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Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
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Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
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More from Policy & Regulation

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

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Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.