As part of FDA’s Real-World Evidence (RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials (RCTs) with streamlined protocols and procedures that focus on essential data collection, allowing integration of...
This report on mobile health (mHealth) data is available to explore the opportunities of using data from mobile technologies and digital interventions in regulatory decision-making. This report focuses on mHealth data use in real-world settings,...
The FDA has issued a draft guidance which provides recommendations to sponsors who are considering submitting a non-interventional/observational study proposal to the FDA. This draft guidance was developed in response to stakeholders’ growing interest in the potential...
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance [Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice] that’s intended to pave the way for using data...
Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at...
The reflection paper adopted in June 2024 aims “to harmonise real-world evidence terminology. It also looks to enable the convergence of general principles for planning and reporting studies using real-world data to support regulatory decision-making.” The reflection paper identifies the...
The EMA published its 2nd report on the Real-world evidence framework to support EU regulatory decision-making for the period between February 2023 and February 2024. This report builds on the experience previously acquired during the...
This Data Protection Notice explains the most essential details of the processing of personal data by the European Medicines Agency (hereinafter “EMA” or “Agency”) in the context of the collection/maintenance and public dissemination of information...
The EMA published all the presentation materials and the video recording of the Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods. This one-day hybrid Big Data Steering Group (BDSG) workshop brings...
The EMA jointly with the HMA issued a guide on how it can help generate real-world evidence. This document briefly describes how RWE, derived from the analysis of RWD, can be useful in the context...
