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; Small Entity Compliance Guide; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "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." We are issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the "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" (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating 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 and establishes standards to help ensure this requirement is met. The term "drugs" in this guidance refers to prescription human drug and biological products.