CNPR Healthcare Industry Knowledge & Drug Approval Process 2

Question 1

Which FDA center is primarily responsible for reviewing and approving new prescription drugs?

Accepted Answer

Center for Drug Evaluation and Research (CDER)

Answer

CDER oversees the safety and efficacy of prescription and over-the-counter drugs for human use.

Question 2

What is the purpose of a Phase II clinical trial?

Accepted Answer

To evaluate efficacy and side effects in patients with the target disease

Answer

Phase II trials assess whether the drug works in patients who have the condition and further evaluate its safety profile.

Question 3

A drug that receives Orphan Drug Designation from the FDA is intended to treat a disease affecting fewer than how many people in the US?

Accepted Answer

200,000

Answer

The Orphan Drug Act defines a rare disease as one affecting fewer than 200,000 people in the United States.

Question 4

Which of the following best describes a formulary in the context of managed care?

Accepted Answer

A preferred list of medications covered under a health plan

Answer

A formulary is a list of drugs approved for coverage by an insurance or managed care plan, often categorized into tiers.

Question 5

What does the term 'off-label' use of a drug mean?

Accepted Answer

The drug is used for a purpose not listed on its FDA-approved label

Answer

Off-label use refers to prescribing an approved drug for an indication, population, or dosage not specified in its FDA labeling.

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