Which condition would exempt a study from requiring an IND?

The idea of requiring an Investigational New Drug (IND) application primarily revolves around the need to ensure that there is adequate oversight and safety for studies involving investigational drugs. An IND is typically necessary when a clinical investigation aims to evaluate an unapproved drug or an existing drug for a new indication or different patient population.

The condition that a study is not intended to be reported to the FDA suggests that the findings will not contribute to the drug’s marketing or approval process and therefore may not necessitate regulatory scrutiny. If the research is solely for internal use, such as for preliminary exploration of a drug's effects without the goal of moving towards commercialization, it could fall outside the requirements of needing an IND.

This context aligns with the FDA's regulations whereby studies aimed strictly at gathering internal data or developing academic understanding without plans for broad distribution or regulatory submission might be exempt from IND requirements. In contrast, studies that support a new drug indication, significantly increase risk to subjects, or involve an investigational drug with a certain number of subjects would typically require an IND to ensure subject safety and compliance with regulatory standards.