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.
- Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
- Guidelines 07/2020 on the concepts of controller and processor in the GDPR
- NOVAS DATAS para a formação sobre as BOAS PRÁTICAS DE DISTRIBUIÇÃO DE MEDICAMENTOS E DISPOSITIVOS MÉDICOS
- FDA NEW GUIDANCE : “Biological evaluation of medical devices
- NEW MDSAP DOCUMENT: mdsap audit approach.
- The European Commission has published a frequently asked questions document (FAQs) on UDI System
- COSMETIC BORDELINE MANUAL. SEPT 2020
- EC: Updated version 18 of Q&A on safety features for medicinal products for human use