Description
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.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Early-phase randomized, double-blind, parallel assignment clinical study
Requires analytical comparability per ICH Q5E
guidance applies to drugs regulated under section 505
Stakeholders
2Entity responsible for submitting NDINs
Target audience for the compliance guide
Regulatory Context
Regulatory Activities
1Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format
Document Types
2Full risk information viewers/listeners are directed to
Type of guidance document prepared under the Small Business Regulatory Fairness Act
Attributes
3The required manner of presentation for the major statement
November 20, 2024
Required standard for the presentation of the major statement
Technical Details
Clinical Concepts
3The content contained within the major statement
Situations where device should not be used
Information required in the major statement
Standards & References
External Standards
1Federal Register citation for the CCN Final Rule
Related CFR Sections (1)
- 21CFR202.1§ 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →
See Also (7)
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)
- Regulatory Considerations for Prescription Drug Use-Related Software (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Consumer-Directed Broadcast Advertisements: Guidance for Industry (Status: Final)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Status: Draft)