CNPR FDA Regulations 2

Question 1

Which FDA regulatory pathway allows a drug manufacturer to sell a generic drug after the brand-name drug's exclusivity period expires?

Accepted Answer

ANDA (Abbreviated New Drug Application)

Answer

An ANDA allows generic manufacturers to market a drug by proving bioequivalence to the reference listed drug without repeating full clinical trials.

Question 2

Under the FDA's regulations, what is the primary purpose of a Risk Evaluation and Mitigation Strategy (REMS)?

Accepted Answer

To ensure the benefits of a drug outweigh its serious risks

Answer

REMS are required when FDA determines that additional safety measures beyond labeling are necessary to ensure a drug's benefits outweigh its risks.

Question 3

The FDA's Orange Book is an official publication that lists which of the following?

Accepted Answer

Approved drug products with therapeutic equivalence evaluations

Answer

The Orange Book (formally 'Approved Drug Products with Therapeutic Equivalence Evaluations') helps identify generic equivalents to brand-name drugs.

Question 4

What does the FDA's 'black box warning' (also called a boxed warning) signify?

Accepted Answer

The drug carries the most serious safety warnings required by the FDA

Answer

A boxed warning is the strongest warning the FDA requires and alerts prescribers to serious or life-threatening risks associated with a medication.

Question 5

Which federal law established the framework requiring manufacturers to prove drug safety AND efficacy before FDA approval?

Accepted Answer

Kefauver-Harris Drug Amendment of 1962

Answer

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.

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(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR FDA Regulations 2