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 : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Direct-to-Consumer Advertising -- legislation & jurisprudence Drug Industry Government Regulation Legislation, Drug Prescription Drugs United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- 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), requires that human prescription drug 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. The major statement provides information relating to the major side effects and contraindications of an advertised prescription drug. Note that this is a selected presentation of the major side effects and contraindications of the drug and not a listing of every risk. DTC TV/radio ads are required to include a major statement. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (6 pages))
- NLM Unique ID:
- 9918751182406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918751182406676