FDA Clinical Hold Orders

This practice note discusses clinical hold orders issued by the U.S. Food and Drug Administration (FDA) to sponsors of investigational new drug (IND) applications, including grounds for issuing a clinical hold order, how the FDA issues an order, and how a sponsor should respond to a clinical hold order to ensure a timely review.

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• Investigational New Drug Transfer Checklist
  Understand how to transfer ownership of an IND to a new sponsor and how to transfer investigational obligations under an IND to a new investigator.

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