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Print Article: KA-03941

Do I need to register each single-patient investigational new drug application (IND) or protocol exception (including for emergency use) separately?

No, manufacturers or Sponsors accepting requests for single-patient investigational new drug applications (INDs) or protocol exceptions (including for emergency use) should provide only one expanded access record to describe the entire expanded access program.

See the Registering Expanded Access Program section of the How to Register Your Study for more information.