Treatment / Single Subject IND Investigational New Drug Applications

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.

Resources

• sIND Checklist
• sIND Annual Report Template
• sIND/eIND Process Flow
• sIND Cover Letter Template
• sIND Training Module
• FDA guidance regarding expanded access IND applications
• FDA Form 3926
• Frequently Asked Questions