A new report from the European Medicines Agency (EMA) demonstrates the utility of real-world data (RWD) studies to answer research questions and support regulatory decision making. But EMA also ...

Regulatory focus theory distinguishes two principal motivational orientations that guide how individuals pursue goals and make choices. A promotion focus drives people to seek gains, ideals and ...

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...

Expediting regulatory guidance for RWE in medical devices: Why it matters for patients Real-world evidence (RWE) can enhance our understanding of the safety, performance, and effectiveness of medical ...

Multiple consortia have been established in the past two decades with the aim of tackling roadblocks in the development of medical products, often by developing new tools to support decision making by ...

Specifically, the upgrade – named ‘explore mode’ – concerns decision-making across pre- and post-trade controls, allowing for full traceability in each step of traders’ transactions. Speaking to The ...

Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based ...

For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA. Notable regulatory decisions include the first drug approval for a prevalent ...