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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. NDA and BLA Approvals
  7. Breakthrough Therapy Approvals
  1. NDA and BLA Approvals

Breakthrough Therapy Approvals

The CDER Breakthrough Therapy (BT) Approvals reports contain a list of approvals for breakthrough therapy designated drugs. New reports will be published quarterly for the current calendar year (CY).

Approvals

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