Question

Which of the following is a criterion for determining if a study of an approved drug is exempt from the require of an IND?

A. The study intends to invoke an exception from informed consent.
B. The study involves a route of administration that significantly increases the risks to the patient.
C. The study is not intended to be reported to FDA to support a new indication or support a labeling change.
D. The study intends to involve more than 100 patients in a study.

Answer 1

The criterion for determining if a study of an approved drug is exempt from the requirement of an IND is if the study is not intended to be reported to FDA to support a new indication or labeling change.

Step-by-step explanation:

The criterion for determining if a study of an approved drug is exempt from the requirement of an Investigational New Drug (IND) is option C: The study is not intended to be reported to FDA to support a new indication or support a labeling change.

When a study is not intended to support a new indication or labeling change, it may be considered exempt from the IND requirement. This means that the study can proceed without the need for submitting an IND application to the FDA.

For example, if the study is a post-marketing surveillance study that aims to gather additional safety data on the approved drug, it may be exempt from the IND requirement. However, it's important to note that even if a study is exempt from the IND requirement, it still needs to comply with other regulatory and ethical requirements.