CRAP CRAP Labeling & Advertising Regulations

Question 1

Under FDA regulations, what must appear on the principal display panel (PDP) of a drug product label?

Accepted Answer

Statement of identity and net quantity of contents

Answer

The PDP must include the statement of identity and net quantity of contents per FDA labeling requirements under 21 CFR Part 201.

Question 2

Which FDA regulation governs the labeling of over-the-counter (OTC) and prescription drug products?

Accepted Answer

21 CFR Part 201

Answer

21 CFR Part 201 contains the general labeling requirements applicable to both OTC and prescription drug products.

Question 3

What is the regulatory significance of a 'boxed warning' (black box warning) in FDA drug labeling?

Accepted Answer

The most serious FDA warning highlighting significant safety risks

Answer

A boxed warning is the FDA's most serious warning, placed in a black-bordered box to prominently highlight significant safety risks to prescribers.

Question 4

Which FDA office is responsible for regulating direct-to-consumer (DTC) prescription drug advertising?

Accepted Answer

FDA Office of Prescription Drug Promotion (OPDP)

Answer

The FDA's Office of Prescription Drug Promotion (OPDP) regulates DTC prescription drug advertising to ensure it is truthful and not misleading.

Question 5

What does 'fair balance' require in pharmaceutical advertising?

Accepted Answer

Presenting risks and benefits with comparable emphasis and prominence

Answer

Fair balance requires that risk information be presented with similar prominence and emphasis as benefit information in drug promotional materials.

(CRAP) Certified Regulatory Affairs Professional Practice Test