Healthcare Industry Knowledge & Drug Approval Process Flashcards

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

Answer: Center for Drug Evaluation and Research (CDER)

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

What is the purpose of a Phase II clinical trial?

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.

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?

Answer: 200,000

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

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

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.

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

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.

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?

Answer: Accelerated Approval

Accelerated Approval allows earlier approval using a surrogate endpoint, with the requirement that the company conduct confirmatory trials.

In the pharmaceutical industry, what is a 'detail' in the context of sales?

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.