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GUIDANCE DOCUMENT

Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers December 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-N-0582
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to help small entities understand and comply with the standards established in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule) (88 FR 80958, November 21, 2023). Section 502(n) of the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA),2 requires that human prescription drug3 advertisements presented directly to consumers (DTC) in television or radio format that state the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications (“major statement”) in a clear, conspicuous, and neutral manner. The CCN Final Rule modifies 21 CFR 202.1(e)(1) to reflect this requirement and establishes standards to help ensure the major statement in these advertisements is presented in the manner required.

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All written comments should be identified with this document's docket number: FDA-2009-N-0582.

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