CNPR Healthcare Industry Knowledge & Drug Approval Process 2 — Questions and Answers
Question 1: Which FDA center is primarily responsible for reviewing and approving new prescription drugs?
- Center for Biologics Evaluation and Research (CBER)
- Center for Drug Evaluation and Research (CDER) (Correct answer)
- Center for Devices and Radiological Health (CDRH)
- Center for Food Safety and Applied Nutrition (CFSAN)
Correct answer: Center for Drug Evaluation and Research (CDER)
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?
- To determine the drug's toxicity in animal models
- To test safety in a small group of healthy volunteers
- To evaluate efficacy and side effects in patients with the target disease (Correct answer)
- To compare the new drug to existing standard-of-care treatments in large populations
Correct answer: To evaluate efficacy and side effects in patients with the target disease
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?
- 100,000
- 200,000 (Correct answer)
- 500,000
- 1,000,000
Correct answer: 200,000
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?
- A legal document listing FDA-approved drugs
- A preferred list of medications covered under a health plan (Correct answer)
- A record of a patient's prescription history
- A schedule for dispensing controlled substances
Correct answer: A preferred list of medications covered under a health plan
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?
- The drug is being sold without FDA approval
- The drug is used for a purpose not listed on its FDA-approved label (Correct answer)
- The drug's patent has expired and generics are available
- The drug is being prescribed by a non-licensed practitioner
Correct answer: The drug is used for a purpose not listed on its FDA-approved label
Off-label use refers to prescribing an approved drug for an indication, population, or dosage not specified in its FDA labeling.
Question 6: Which regulatory pathway allows the FDA to approve drugs for serious conditions based on a surrogate endpoint that is reasonably likely to predict clinical benefit?
- Standard review
- Priority Review
- Accelerated Approval (Correct answer)
- Fast Track designation
Correct answer: Accelerated Approval
Accelerated Approval allows earlier approval using a surrogate endpoint, with the requirement that the company conduct confirmatory trials.
Question 7: In the pharmaceutical industry, what is a 'detail' in the context of sales?
- A written summary of clinical trial results submitted to the FDA
- A face-to-face presentation by a sales representative to a healthcare provider about a drug (Correct answer)
- A list of drug samples left with a physician's office
- A reimbursement claim submitted to a payer
Correct answer: A face-to-face presentation by a sales representative to a healthcare provider about a drug
Detailing refers to the core activity of pharmaceutical sales reps — personally presenting product information to physicians and other prescribers.
CNPR Healthcare Industry Knowledge & Drug Approval Process 2
Which FDA center is primarily responsible for reviewing and approving new prescription drugs?