CRAP Labeling & Advertising Regulations Flashcards
6 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRAP Labeling & Advertising Regulations flashcards as text
Which type of labeling change to an NDA requires a Prior Approval Supplement (PAS)?
Answer: Adding a new boxed warning based on post-market safety data
Adding a new boxed warning requires a Prior Approval Supplement because it represents a significant safety labeling change that must be reviewed and approved by FDA before implementation.
What does the 'PLR' format refer to in FDA prescription drug labeling?
Answer: Physician's Labeling Rule format for structured prescriber labeling
The Physician's Labeling Rule (PLR), effective 2006, restructured prescription drug package inserts into standardized sections to improve usability for healthcare professionals.
Under which regulation must medical device labels include a Unique Device Identifier (UDI)?
Answer: 21 CFR Part 830
21 CFR Part 830 establishes the UDI system requirements, mandating that medical device labels include a unique device identifier for traceability throughout the supply chain.
What is a 'reminder advertisement' in pharmaceutical promotion?
Answer: An ad that names a drug but makes no efficacy or safety claims about it
A reminder advertisement names a drug but makes no claims about it, which exempts it from the fair balance requirement for presenting risk information.
Which best describes a 'help-seeking' advertisement in pharmaceutical promotion?
Answer: An ad that describes a condition and directs consumers to speak with their doctor
A help-seeking ad describes a disease or condition and encourages consumers to consult their physician, without mentioning a specific drug, and is regulated by the FTC rather than FDA.
Under FDA's labeling requirements, which section of a drug's prescribing information must describe potential adverse reactions identified in clinical trials?
Answer: Adverse Reactions
The Adverse Reactions section of the prescribing information is specifically designated to describe undesirable effects observed in clinical trials and post-marketing experience.