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US FDA center to which the IND or IDE was submitted, and that holds the IND/IDE approval:

  • For IND:
    • Center for Drug Evaluation and Research (CDER)
    • Center for Biologics Evaluation and Research (CBER)
  • For IDE:
    • Center for Devices and Radiological Health (CDRH)
    • Center for Biologics Evaluation and Research (CBER)