Product Labeling and Advertising Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Product Labeling and Advertising flashcards as text
Under ICH E6(R2) Good Clinical Practice, which document serves as the primary regulatory reference for labeling investigational medicinal products in clinical trials?
Answer: The Investigator's Brochure, which contains the clinical and nonclinical data about the investigational product
ICH E6(R2) designates the Investigator's Brochure as the key reference document for IMP labeling and the basis for the reference safety information.
Canada's Food and Drug Regulations require bilingual labeling (English and French) for foods. Under which law is this requirement enforced?
Answer: The Consumer Packaging and Labelling Act, enforced by Health Canada and the CFIA
The Consumer Packaging and Labelling Act and the Safe Food for Canadians Regulations require bilingual labeling, with enforcement shared between Health Canada and CFIA.
A pharmaceutical company's TV advertisement for a prescription drug uses rapid voice-over to present risk information. Under 21 CFR 202.1(e)(1), what is this technique called and what is FDA's position on it?
Answer: The 'adequate provision' standard requires that audio risk information be presented in a way that consumers can hear and understand
FDA's guidance on DTC broadcast advertising requires risk information to be presented in a manner that is understandable to the intended audience, not obscured by speed or technical jargon.
Under 21 CFR Part 314 for NDAs, which labeling revision process allows a manufacturer to implement a minor labeling change without any FDA notification?
Answer: Annual Report changes for minor editorial or formatting corrections that do not affect content
Purely editorial or formatting changes that do not alter meaning may be reported in the Annual Report rather than requiring a supplement submission.
Japan's Pharmaceutical and Medical Devices Act (PMDA) requires that prescription drug package inserts (添付文書) prominently include which item in the 'Warnings' section?
Answer: Contraindications and precautions that could result in death or serious adverse reactions if not followed
Under PMDA guidelines, the Warnings (警告) section is reserved for the most critical safety information where non-compliance could result in death or serious harm.
The FDA's Prescription Drug Labeling rule (21 CFR 201.56 and 201.57) introduced the Highlights section for prescription drug labeling. What information is prohibited from appearing only in Highlights?
Answer: Information may not appear only in Highlights if it also belongs in the full prescribing information — it must appear in both sections
Under 21 CFR 201.57, any information in Highlights must also appear in the full prescribing information; Highlights cannot contain unique information not found elsewhere.
Which EU regulatory concept requires that advertising for medicines directed at the general public must not suggest that a medical consultation or surgical operation is unnecessary?
Answer: Directive 2001/83/EC Article 90, which prohibits advertising that discourages appropriate medical care
Article 90 of Directive 2001/83/EC explicitly lists prohibited content in consumer-directed medicine advertising, including suggestions that medical consultation is unnecessary.