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.
- Framework for the Use of Digital Health Technologies in Drug and Biological Product Development
- Advancing regulatory science in the EU – mid-point report published
- Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- Gestão de Risco no âmbito das Boas Práticas de Distribuição : “Formação muito bem conseguida com aplicabilidade prática”
- EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME : Audit Checklist
- MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
- Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
- Artificial Intelligence in Drug Manufacturing.