Healthcare Industry Knowledge & Drug Approval Process Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Healthcare Industry Knowledge & Drug Approval Process flashcards as text
What is the primary function of the FDA's MedWatch program?
Answer: To monitor and collect voluntary adverse event and safety reports from healthcare professionals and consumers
MedWatch is the FDA's safety information and adverse event reporting program, allowing voluntary reporting by clinicians and mandatory reporting by manufacturers.
In pharmaceutical marketing, what does 'share of voice' measure?
Answer: A company's promotional spending or sales force activity relative to competitors in the same therapeutic category
Share of voice quantifies how much of the total promotional effort in a market a company controls compared to its competitors, often correlating with market share.
Which of the following best describes a 'prior authorization' (PA) requirement in pharmacy benefits?
Answer: A health plan requires prescribers to obtain approval before covering a specific medication, often by demonstrating medical necessity
Prior authorization is a managed care cost-control tool requiring prescribers to justify medical necessity before the plan will cover certain high-cost or specialized drugs.
The Hatch-Waxman Act of 1984 achieved which two primary goals for the pharmaceutical industry?
Answer: It expedited generic drug approval via ANDAs and allowed brand manufacturers to extend patent terms lost during development
Hatch-Waxman simultaneously created the ANDA pathway for faster generic entry and granted brand companies patent term restoration to compensate for regulatory review time.
A pharmaceutical company launches a Risk Evaluation and Mitigation Strategy (REMS) for a drug. What does this indicate?
Answer: The FDA determined the drug's benefits outweigh its risks only if specific safety measures are in place to manage serious risks
REMS programs are required by FDA when a drug poses serious risks that can be managed only through restricted distribution or required safety protocols, not through labeling alone.
Which of the following statements about Continuing Medical Education (CME) is most consistent with PhRMA guidelines?
Answer: Commercially supported CME must be independent of the funding company's promotional interests
PhRMA guidelines and ACCME standards require that commercially supported CME be free from promotional bias and controlled independently by the accredited provider.
A drug's package insert (PI) is also referred to as the 'label.' Who is the primary intended audience for this document according to FDA regulations?
Answer: Healthcare professionals, as the PI contains full prescribing information for clinical decision-making
The FDA-approved prescribing information (package insert) is directed at licensed healthcare professionals and contains the complete clinical data, dosing, warnings, and contraindications.