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In this section: IND Activity

Breakthrough Therapy Designation Requests

The CDER Breakthrough Therapy (BT) Designation Requests reports contain a count of breakthrough therapy designations received and the status of these requests. New reports will be published quarterly for the current fiscal year (FY).

Current FY CDER BT Totals (PDF - 66 KB)
Previous Cumulative FY CDER BT Totals (PDF - 74 KB)

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