NUR 615 PHARM EXAM 1 GENERAL
WITH 100% CORRECT ANSWERS
2026
What does the FDA do? correct answers >> The U.S. Food
and Drug Administration regulates: The official labeling for all
prescription and over-the-counter drugs
What is phase IV clinical trials in the United States also known as?
correct answers >> Postmarketing research
What is off label prescribing? correct answers >> Off-label
use is the use of pharmaceutical drugs for an unapproved
indication or an unapproved age group, dosage or route of
administration. Both prescription drugs and over-the- counter
drugs can be used in off-label ways, although most studies of off-
label use focus on prescription drugs.
Insurance may not pay for off-label use. i.e. Wellbutrin for
smoking cessation.
Is off label prescribing legal? correct answers >> Off-label
use is generally legal unless it violates ethical guidelines for
safety regulations. it is commonly used to good effect by
physicians and nurse practitioners because we understand how to
, use it correctly. However, it can entail health risks and differences
and legal liability.
When should an investigational new drug be filed with the FDA
correct answers >> Prior to any human testing of any new drug
entity.
What needs FDA approval prior to being put in the market for
sale? correct answers >> Medical devices including artificial
joints.
When should be FDA MedWatch system be activated? correct
answers >> When an adverse effect or serious problem occurs
with a medication that is not already identified on the label.
Under new U.S. Food and Drug Administration labeling, Pregnancy
Categories will be correct answers >> Changed to
incorporate a pregnancy risk summary and clinical considerations
on the drug label
What is pharmacodynamics? correct answers >> The study
of what a medication does to the body
What is pharmacokinetics? correct answers >> The study of
drug movement throughout the body
What is pharmacotherapeutics? correct answers >>
Pharmacotherapeutics is the clinical purpose or indication for
giving a drug
WITH 100% CORRECT ANSWERS
2026
What does the FDA do? correct answers >> The U.S. Food
and Drug Administration regulates: The official labeling for all
prescription and over-the-counter drugs
What is phase IV clinical trials in the United States also known as?
correct answers >> Postmarketing research
What is off label prescribing? correct answers >> Off-label
use is the use of pharmaceutical drugs for an unapproved
indication or an unapproved age group, dosage or route of
administration. Both prescription drugs and over-the- counter
drugs can be used in off-label ways, although most studies of off-
label use focus on prescription drugs.
Insurance may not pay for off-label use. i.e. Wellbutrin for
smoking cessation.
Is off label prescribing legal? correct answers >> Off-label
use is generally legal unless it violates ethical guidelines for
safety regulations. it is commonly used to good effect by
physicians and nurse practitioners because we understand how to
, use it correctly. However, it can entail health risks and differences
and legal liability.
When should an investigational new drug be filed with the FDA
correct answers >> Prior to any human testing of any new drug
entity.
What needs FDA approval prior to being put in the market for
sale? correct answers >> Medical devices including artificial
joints.
When should be FDA MedWatch system be activated? correct
answers >> When an adverse effect or serious problem occurs
with a medication that is not already identified on the label.
Under new U.S. Food and Drug Administration labeling, Pregnancy
Categories will be correct answers >> Changed to
incorporate a pregnancy risk summary and clinical considerations
on the drug label
What is pharmacodynamics? correct answers >> The study
of what a medication does to the body
What is pharmacokinetics? correct answers >> The study of
drug movement throughout the body
What is pharmacotherapeutics? correct answers >>
Pharmacotherapeutics is the clinical purpose or indication for
giving a drug
