Nursing Pharmacology Practice Questions – Drug Approval Process

Welcome to your Nursing Pharmacology Practice Questions – Drug Approval Process

Agency In Charge of Drug Approval

Which agency is responsible for final approval of medications that will allow them to be marketed and sold in the United States?

Adverse Drug Reaction Reporting

A nurse feels that the use of a medication led to hepatic failure and the death of a patient. Where would it be most appropriate to report this possible adverse event?

Phases of Clinical Trials

In which phase of drug development is a medication first tested in humans?

Phases of Clinical Trials 2

Following which phase of drug development would a drug company be able to apply for a new drug application (NDA)?

Post Marketing Surveillance

What is a primary goal of post-marketing surveillance?

Abbreviated New Drug Application

Which best describes an Abbreviated New Drug Application?

Phase of Trial Identification

Prior to approval of a medication, which phase of clinical trials typically enrolls the highest number of clinical trial participants?


Which of the following best describes a formulary?

Institution In Charge of Controlled Medication

Which institution is primarily responsible for classifying medications as controlled substances?

USP Purpose

Which of the following aligns with the purpose of the United States Pharmacopeia (USP)?