Withdrawing an Investigational New Drug (IND) Application Quiz
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Questions and Answers

What is the consequence of withdrawing an effective IND?

  • The sponsor loses all rights to the drug
  • The sponsor is required to continue the clinical investigations
  • All clinical investigations conducted under the IND shall be ended (correct)
  • FDA takes over the clinical investigations

    • When can a sponsor withdraw an effective IND without prejudice?

  • At any time (correct)
  • Only if FDA approves
  • If the drug is not in demand
  • If there are no ongoing clinical investigations

    • What should a sponsor do if an IND is withdrawn due to safety reasons?

  • Notify the investigators after a month
  • Dispose of the drug without informing FDA
  • Promptly inform FDA (correct)
  • Continue the clinical investigations

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