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?
Terminology
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)?
