When determining if an IND needs to be submitted to study marketed drugs for treating cancer, investigators must apply the exemption criteria listed in § 312.2(b)(1)(i-v). Planned studies may be considered exempt from the requirements of an IND if the studies involve a new use, dosage, schedule, route of administration, or new combination of marketed cancer products in a patient population with cancer and the following conditions apply:

• The studies are not intended to support FDA approval of a new indication or a significant change in the product labeling.
• The studies are not intended to support a significant change in the advertising for the product.
• Investigators and their IRBs determine that based on the scientific literature and generally known clinical experience, there is no significant increase in the risk associated with the use of the drug product.
• The studies are to be conducted in compliance with IRB and informed consent regulations.
• The studies will not be used to promote unapproved indications.

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