Regulatory Affairs Certification (RAC) Practice Exam 2026 - Free RAC Practice Questions and Study Guide

An Investigational New Drug Application (IND) goes inactive under specific circumstances that reflect a lack of progress in the clinical study or issues that prevent it from moving forward. One key scenario is when no subjects are entered into the clinical trial for a period of two years. This inactivity indicates that the study has stalled, which could lead regulatory authorities to consider the IND no longer in use.

Additionally, if the IND is placed on a clinical hold for a continuous period of one year, that also contributes to its inactive status. A clinical hold may occur for various reasons, such as safety concerns or deficiencies in the study design, and if no resolution or progress is made within that timeframe, the IND is designated as inactive.

Consequently, both scenarios—no subjects being entered for two years and being on clinical hold for one year—are valid reasons for an IND to be considered inactive. This makes the chosen answer correct, as it encompasses the two situations that lead to the inactivity of an Investigational New Drug Application.