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

This article was originally published in RPM Report

Executive Summary

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.

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