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Can US FDA's Talk Therapy Cure What Ails Mental Health R&D?

 
• By Bridget Silverman

By reducing regulatory uncertainty, US FDA’s Breakthrough Therapy Designation is helping adventurous sponsors try new trial designs and new mechanism in the long-stagnant field of psychiatry drug development. 

concept graph brain wave EEG
Can BTD help FDA and sponsors get on the same brainwave length?

The enhanced communication with the US FDA afforded by a Breakthrough Therapy Designation (BTD) is already helping to reduce uncertainty in psychiatry R&D, and could help to produce the first new mechanisms of action in decades.

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