Which criterion indicates a study of an approved drug does not require an IND?

For a clinical study involving an already approved drug, an Investigational New Drug (IND) application is generally not required if the study will not be reported to the FDA for new indications. This indicates that the research is simply exploring aspects of the drug that do not necessitate regulatory oversight for new uses or risks associated with the drug. It implies that the use of the drug is consistent with its approved labeling and intended use, which falls under a framework that typically does not require an IND.

In the context of the other options, the first choice regarding the number of patients does not directly correlate with the need for an IND, as studies can involve varying numbers of patients regardless of the IND requirement status. The second option concerning increased patient risks is significant since any study that introduces new risks or alters administration routes could necessitate an IND to ensure participant safety and regulatory compliance. Lastly, the option regarding seeking an exception from informed consent suggests ethical concerns tied to study design but does not inherently relate to the requirements for an IND. Thus, the criterion about not reporting to the FDA for new indications clearly indicates the bounds within which the existing drug is being used and avoids the need for an IND.