1. Pink Sheet

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

More from Approval Standards

More from Pathways & Standards