CITI Training Practice Exam

When does a sponsor submit the IND?

1. After the NDA submission

2. During Phase IV

3. Prior to clinical development phases

4. After preclinical trials

The correct answer is: Prior to clinical development phases

A sponsor submits an Investigational New Drug (IND) application prior to conducting clinical trials in humans. It is the first step in the clinical trial process and must be submitted to the FDA for approval before any human studies can begin. Option A is incorrect because an NDA (New Drug Application) is submitted after all clinical trials are completed and before the drug can be approved for marketing. Option B is incorrect because Phase IV trials occur after a drug has been approved and are used to gather additional information about the drug's safety and effectiveness. Option D is incorrect because preclinical trials are conducted before an IND submission and are used to gather initial safety and efficacy data in animal models.