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What are the requirements that allow planned studies to be exempt from IND requirements?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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