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US FDA Explains How It Is Embracing Remote Assessments Post-Pandemic

 
• By Bowman Cox

Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.

Virtual inspection
• Source: Shutterstock

The US Food and Drug Administration will continue remote regulatory assessments of drug manufacturing plants, clinical investigator sites and other regulated facilities after the COVID-19 pandemic no longer prevents travel for site inspections, the agency says in a draft guidance.

In a notice scheduled for publication in the 25 July Federal Register, the agency also offers some insight into why...

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Proponent For Age-Restricting Diet Supplement Sales Adds ‘Health Inequities’ To Argument

 
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• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.

Givaudan Has UTI Health Claim Turned Down In EU

 
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More from Policy & Regulation

US FDA Supplement Office Chief Eyes ‘Movement’ This Year On NDI Notifications Final Guidance

 
• By Malcolm Spicer

“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.

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• By David Ridley

Germany’s Federal Institute for Risk Assessment says that there is "no evidence that people with androgenetic alopecia have special dietary needs or a special nutrient requirement.”