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U.S. Food and Drug Administration
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  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. IND Activity
  7. Breakthrough Therapy Designation Requests
  1. 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). 

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