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Treatment / Single Subject IND Investigational New Drug Applications
Last Updated 5 months 1 week ago
This section provides information for investigators that helps determine:
- If a Single Subject IND (sIND; also known as a “Treatment IND”) is needed,
- The process of applying to the FDA for an sIND, and
- investigator responsibilities.
Additionally, the IND/IDE Support Office is a resource for investigators who would like to consult regarding study protocol design.
A Treatment IND/sIND allows an experimental drug (or biologic) to be used to treat a patient while clinical testing and FDA review are still taking place. It is only approved for serious or life-threatening conditions.
Examples of when a Treatment IND/sIND may be needed:
- A CHOP physician is caring for an individual patient who may benefit from the use of an investigational drug (or biologic).
- The investigational drug administration needs to occur within several days to weeks for a patient.
- A serious or immediately life-threatening disease or condition exists, and there is no comparable or satisfactory alternative therapy to treat, monitor or diagnose the disease or condition in a patient.