The US Food and Drug Administration (FDA) last week published a final guidance detailing five standards drug manufacturers should follow to ensure direct-to-consumer (DTC) radio and television advertisements conform to its regulations. The guidance complements a November 2023 final rule that established the five standards for conveying a major statement in a “clear, conspicuous, and neutral manner.”
The questions and answers guidance addresses issues that manufacturers should consider when making a major statement about their product that the agency considers to be clear, conspicuous and neutral (CCN). (RELATED: FDA issues new standards for DTC prescription drug ads, Regulatory Focus 21 November 2023)…
