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.
- Lançamento do Projeto-piloto de Submissão de Ensaios Clínicos
- Clinical Trials Information System (CTIS): EMA training programme
- IMDRF :Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
- Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
- CLINICAL TRIALS REGULATION:(EU) Nr. 536/2014.
- EMA has published the EU IDMP Implementation Guide version 2.0
- Guideline on good pharmacovigilance practices (GVP) 4 Module XVI – Risk minimisation measures: selection of tools and 5 effectiveness indicators (Rev 3)
- EUDAMED NEWS: management of legacy devices.