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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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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. NDA and BLA Approval Times
  1. NDA and BLA Approvals

NDA and BLA Approval Times

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