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 a New Drug Application (NDA)?
Answer: A formal proposal asking FDA permission to market a new drug in the US
An NDA is submitted to the FDA after clinical trials are complete, containing all data needed to demonstrate safety and efficacy for marketing approval.
Which of the following is a key difference between brand-name and generic drugs?
Answer: Generic drugs must have the same active ingredient, strength, and route of administration as the brand
The FDA requires generics to be bioequivalent — same active ingredient, dosage form, strength, and route of administration — but inactive ingredients may differ.
What is the role of a Pharmacy Benefit Manager (PBM)?
Answer: To manage prescription drug benefits on behalf of health insurers, employers, and government programs
PBMs negotiate drug prices, process claims, and develop formularies on behalf of plan sponsors, making them powerful gatekeepers in pharmaceutical access.
Under the Prescription Drug Marketing Act (PDMA), which of the following is a pharmaceutical sales representative required to do with drug samples?
Answer: Maintain accurate records of samples distributed and obtain a licensed practitioner's signature
The PDMA requires reps to track samples, obtain signatures from licensed practitioners, and maintain records to prevent diversion or fraud.
What is the primary goal of Phase III clinical trials?
Answer: To confirm efficacy and monitor adverse reactions in large patient populations
Phase III trials involve hundreds to thousands of patients and are designed to confirm effectiveness and gather safety data needed for NDA submission.
Which type of healthcare provider has the legal authority to prescribe Schedule II controlled substances in all 50 states?
Answer: Physicians (MDs and DOs)
Licensed physicians hold DEA registration that authorizes them to prescribe Schedule II controlled substances, though Nurse Practitioners and PAs may also have this authority in many states.
What does 'market exclusivity' granted by the FDA protect, and how does it differ from a patent?
Answer: It is an FDA-granted period preventing generic approval regardless of patent status, based on regulatory criteria
Market exclusivity is an FDA regulatory protection that blocks generic applications for a set period (e.g., 5 years for new chemical entities), independent of patent protection.