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US Smoking Cessation Clinical Trials Guidance 'Does Not Envision' Flexibility On Indications

 
• By Malcolm Spicer

FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs for smoking cessation products. NRT developers could find more room for novel product proposals from changes to some phrasing.

• Source: Shutterstock

The US Food and Drug Administration’s final guidance on clinical trials for smoking cessation or related indications largely mirrors the draft industry stakeholders described as leaving little room for approvals of novel NRTs, though changes to some phrasing in the document could offer some relief.

The Center for Drug Evaluation and Research’s

Many “harm reduction” proponents recommend expanding smoking cessation product options along with indications allowed for NRTs, including allowing relief of withdrawal symptoms as a stand-alone

More from Regulation

More from Policy & Regulation

US Tariffs Pose ‘Existential Threat’ To EU Medical Devices Industry

 
• By David Ridley

AESGP, MedTech Europe and other associations representing medtech companies including manufacturers of self-care devices call for such products to be included in European Commission proposals for “zero-for-zero” trade in industrial goods between Europe and the US.

Stakeholders Hope US FDA’s Proposed Animal Test Phase-Out For Drugs Will Extend To OTCs, Cosmetics

 
• By Eileen Francis and Lauren Nardella

The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.