CRAP CRAP Labeling & Advertising Regulations 1

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

Brand name only

Answer

List of inactive ingredients

Answer

Manufacturer contact information

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 207

Answer

21 CFR Part 314

Answer

21 CFR Part 600

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 warning about drug interactions listed in bold font

Answer

A warning specific to pediatric populations only

Answer

A warning about environmental disposal requirements

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

Federal Trade Commission (FTC)

Answer

FDA Division of Drug Information

Answer

NIH Office of Consumer Affairs

Question 5

What does 'fair balance' require in pharmaceutical advertising?

Accepted Answer

Presenting risks and benefits with comparable emphasis and prominence

Answer

Equal airtime for brand and generic drugs

Answer

Balancing the number of ads for competing products

Answer

Ensuring equal representation of patient demographics

Question 6

Under 21 CFR Part 202, what is required in prescription drug advertisements?

Accepted Answer

Full prescribing information or a brief summary of key safety information

Answer

Cost comparison with competitor drugs

Answer

Patient testimonials approved by FDA

Answer

Color-coded safety ratings