Can US FDA's Talk Therapy Cure What Ails Mental Health R&D?
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.
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The latest drug development news and highlights from our US FDA Performance Tracker.
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.
Externally hosted patient focused drug development meeting in MDD brings timely messages to US FDA during period of active regulatory review of new applications. Patients stress need for fewer side effects to encourage long-term medication use, and also want fast-acting meds that can “jump start” lifestyle changes.