FDA Regulations 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 FDA Regulations flashcards as text
Which FDA regulatory pathway allows a drug manufacturer to sell a generic drug after the brand-name drug's exclusivity period expires?
Answer: ANDA (Abbreviated New Drug Application)
An ANDA allows generic manufacturers to market a drug by proving bioequivalence to the reference listed drug without repeating full clinical trials.
Under the FDA's regulations, what is the primary purpose of a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: To ensure the benefits of a drug outweigh its serious risks
REMS are required when FDA determines that additional safety measures beyond labeling are necessary to ensure a drug's benefits outweigh its risks.
The FDA's Orange Book is an official publication that lists which of the following?
Answer: Approved drug products with therapeutic equivalence evaluations
The Orange Book (formally 'Approved Drug Products with Therapeutic Equivalence Evaluations') helps identify generic equivalents to brand-name drugs.
What does the FDA's 'black box warning' (also called a boxed warning) signify?
Answer: The drug carries the most serious safety warnings required by the FDA
A boxed warning is the strongest warning the FDA requires and alerts prescribers to serious or life-threatening risks associated with a medication.
Which federal law established the framework requiring manufacturers to prove drug safety AND efficacy before FDA approval?
Answer: Kefauver-Harris Drug Amendment of 1962
The Kefauver-Harris Amendment of 1962 required drug manufacturers to prove both safety and efficacy before FDA approval, largely in response to the thalidomide tragedy.
Under FDA regulations, which of the following is an example of permitted 'off-label' communication by pharmaceutical representatives?
Answer: Responding to an unsolicited request from a physician with truthful, non-misleading scientific information
FDA guidance permits sharing scientific information about unapproved uses only when responding to unsolicited inquiries from healthcare professionals.
The Prescription Drug Marketing Act (PDMA) of 1987 was enacted primarily to prevent which of the following?
Answer: Diversion and counterfeiting of prescription drugs in the drug supply chain
PDMA was enacted to combat the diversion and counterfeiting of prescription drugs, ensuring the integrity of the pharmaceutical distribution chain.