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Now It Really Is Personal: US FDA 'Rushing' To Develop Policy For 'Bespoke Therapies'

 
• By Laura Helbling

Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.

Mannequin with basted jacket by a tailor - Image
It's a perfect fit, but the US FDA needs a way to see if it measures up.

Recent cases of treatments for single patients have the US Food and Drug Administration hurrying to put together policy of how to handle applications for truly personalized medicines.

During the Biotechnology Innovation Organization annual meeting in Philadelphia, Alnylam Pharmaceuticals Inc

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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
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Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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