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Breakthrough Nears 50 Approvals: Process Improving, But “Gray Areas” Persist

 
• By Kate Rawson

FDA is close to hitting a milestone in the short history of the Breakthrough Therapies designation: 50 indications approved under the abbreviated development and review pathway. In reflecting on the last three-plus years, agency officials say the quality of requests for Breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.

At some point later this year, the Food & Drug Administration will approve the 50th Breakthrough Therapy-designated product application.

As of April 30, FDA had cleared 46 applications (counting new molecules and new indications) that carried the designation; the most recent was Acadia Pharmaceuticals Inc.Nuplazid (pimavanserin) for psychosis...

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