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
A pharmaceutical company submits a Biologics License Application (BLA) instead of an NDA when the product is:
Answer: A large-molecule product derived from living cells or organisms such as a vaccine or monoclonal antibody
BLAs are required for biologics — complex molecules like proteins, antibodies, and gene therapies derived from biological sources — reviewed by CBER or CDER.
Which government program provides prescription drug coverage primarily for Americans aged 65 and older?
Answer: Medicare Part D
Medicare Part D is the voluntary outpatient prescription drug benefit for Medicare beneficiaries, administered through approved private plan sponsors.
What is the significance of a drug's half-life to a pharmaceutical sales representative?
Answer: It influences dosing frequency, which is a key selling point related to patient convenience and adherence
A longer half-life may allow once-daily dosing, which representatives can highlight as improving patient adherence compared to drugs requiring multiple daily doses.
Under the PhRMA Code on Interactions with Healthcare Professionals, which of the following activities is prohibited?
Answer: Giving physicians tickets to a sporting event as a token of appreciation
The PhRMA Code prohibits giving entertainment or recreational items of value, such as sports tickets, regardless of their cost.
What is a 'Paragraph IV certification' in the context of generic drug applications (ANDAs)?
Answer: A certification that the brand's listed patent is invalid or will not be infringed by the generic
A Paragraph IV certification is a legal challenge asserting that listed patents are invalid or will not be infringed, which often triggers 30-month litigation stays.
Which federal law requires pharmaceutical manufacturers to report serious and unexpected adverse drug reactions to the FDA?
Answer: The Federal Food, Drug, and Cosmetic Act (FD&C Act) post-marketing reporting requirements
The FD&C Act's post-marketing surveillance provisions mandate that manufacturers submit MedWatch reports for serious unexpected adverse events discovered after drug approval.
A physician who sees patients primarily in a hospital setting and makes decisions about which drugs appear on the hospital's approved drug list is best described as:
Answer: A hospitalist or specialist influencing the hospital formulary
Hospital-based physicians, including hospitalists and specialists, often serve on Pharmacy and Therapeutics (P&T) committees that control the institutional formulary.