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US FDA OTC Monograph Meetings Guidance Should Be Familiar To Firms Using NDA Pathway

 
• By Malcolm Spicer

Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal for manufacturers, other industry stakeholders to expect meetings soon.

• Source: Alamy

The Food and Drug Administration’s overhauled OTC monograph program resembles the agency’s process for prescription drug applications not only for adding ingredients and indications but also for scheduling meetings application sponsors will have with agency officials.

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

 
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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.