The new US Food and Drug Administration (FDA)’s guidance paper on incorporating voluntary patient preference information over the total product cycle, and what It means for patient organisations, March 30, 2026

Jan Geissler, Founder and CEO of Patvocates, a think tank, consultancy and social enterprise on patient advocacy and patient engagement in research, has analysed the Food and Drug Administration (FDA)’s newly issued guidance paper titled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Guidance for Industry, Food and Drug Administration Staff, and […]

The new US Food and Drug Administration (FDA)’s guidance paper on incorporating voluntary patient preference information over the total product cycle, and what It means for patient organisations, March 30, 2026 Read Post »

“The Added Value of Patient Engagement in Early Dialogue at the European Medicines Agency (EMA): Scientific Advice as a Case Study”, Frontiers in Medicine

  ABSTRACT The European Medicines Agency provides Scientific Advice to medicines developers and patient input has been an integral part of this process for many years. As end users of medicines, patients bring their perspectives to many different processes along EMA’s regulatory pathway, complementing the scientific expertise. While the value of including patients has been

“The Added Value of Patient Engagement in Early Dialogue at the European Medicines Agency (EMA): Scientific Advice as a Case Study”, Frontiers in Medicine Read Post »

The European Medicines Agency (EMA) updates its engagement framework with patients, consumers and their organisations

The European Medicines Agency (EMA) engagement framework aims to Facilitate participation of patients and consumers in regulatory activities all along the entire lifecycle of medicines; Foster the development of guidance and methodologies to increase collection and use of relevant patient experience data in the context of regulatory decision making; Ensure that patients, consumers and their

The European Medicines Agency (EMA) updates its engagement framework with patients, consumers and their organisations Read Post »

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