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Questions and Answers
What is the consequence of withdrawing an effective IND?
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?
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What should a sponsor do if an IND is withdrawn due to safety reasons?
What should a sponsor do if an IND is withdrawn due to safety reasons?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
