This guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs. The disclosure of the product name in promotional labeling and advertisements is important for proper identification and to ensure safe and effective use. This guidance also articulates the circumstances under which FDA intends to refrain from taking enforcement action regarding these requirements. We believe that following this guidance will allow for appropriate advertising and promotion without presenting any public health risk to patients.
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- MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies Revision 5 – February 2025
- Formação, Alteração e Revisão Anual de PREÇOS de MEDICAMENTOS: “Formação muito enriquecedora sobre o tema”
- EU Cosmetics Deadlines – New Rules Effective 01 February 2025
- Biomanufacturing: Europe’s Industrial Future
- Plataforma europeia de monitorização da escassez de medicamentos entrou em funcionamento
- FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
- IMDRF Characterization Considerations for Medical Device Software and Software-Specific Risk
- Commission publishes the Guidelines on prohibited artificial intelligence (AI) practices, as defined by the AI Act.