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Study Suggests Futura’s Drug-Free Erectile Dysfunction Gel Suitable For US OTC Pathway

 
• By David Ridley

The successful completion of a short, non-clinical, human factors study puts Futura Medical's MED3000 erectile dysfunction gel one step closer to OTC device approval in the US.

Hurdles
• Source: Shutterstock

UK R&D firm Futura Medical has cleared the first hurdle on the way to gaining US Food and Drug Administration approval for its drug-free erectile dysfunction gel MED3000 as an OTC medical device.

In a pre-submission meeting last year, the FDA agreed that Futura can make an application for a de novo classification – a newly finalised pathway for low-risk medical products to...

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