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Condom Approved In US With Anal Sex Indication Through FDA Process Encouraging More Proposals

 
• By Malcolm Spicer

With approval, FDA created regulatory classification allowing subsequent devices of same type with same intended use may go through 510(k) pathway, allowing devices to obtain clearance by demonstrating substantial equivalence to a predicate device.

• Source: Alamy

A condom with labeling to help reduce transmission of sexually transmitted infections during anal intercourse has been approved for the first time in the US through a regulatory pathway likely to spur additional proposals for additional condoms to have the indication.

The Food and Drug Administration has authorized Global Protection Corp

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
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At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

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Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
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Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
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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.