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Unpublished And Under Review? US FDA’s CBD Policy Draft Guidance Still Has Industry Talking

 
• By Malcolm Spicer

Supplements containing hemp-derived cannabidiols aren’t typical products subject to FDA’s regulatory oversight, and the document stating its thinking on enforcement in the market submitted to the Office of Management and Budget isn’t a typical draft guidance.

CBD Cannabidiol Marijuana Cannabis Time Clocks Deadline 3d Illustration

An unpublished draft guidance the US Food and Drug Administration submits for White House review and clearance typically sparks little to no speculation by stakeholders on the extent and the details of the documents’ content.

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More from 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.

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.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 
• By Jessica Merrill

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

More from Policy & Regulation

Criticism Of US Progress On Sunscreen Ingredient Innovation Demands OMUFA Hearing Spotlight

 
• By Malcolm Spicer

Discussion of introducing additional OTC sunscreen ingredients escaped a total eclipse criticism of Trump’s health agency layoffs caused. Comments and questions by Republican members joined by several Democrats and focused testimony and answers by witnesses representing the industry and public health groups spotlighted sunscreen.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 
• By Jessica Merrill

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.