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US FDA First's RMAT Designation: Humacyte Got A 'Quick Response'

 
• By Michael Cipriano

Humacyte's bioengineered blood vessel, Humacyl, demonstrated long-term potency in Phase II studies; the product, which will regulated as a biologic, can now benefit from increased interactions with FDA under the the Regenerative Medicine Advanced Therapy program.

With the help of a quick response from the US FDA, Humacyte Inc. appears to have become the first company to receive a Regenerative Medicine Advanced Therapy (RMAT) designation from the agency for its investigational human acellular vessel Humacyl.

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EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
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More from Advanced Technologies

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Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
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AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.