News from the healthcare data industry
Executive Summary EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released...
20 September 2022 | By Mary Ellen Schneider Left to right: Seema Betigeri, Sabine Haubenreisser, Rob Kalesnik-Orszulak PHOENIX, AZ – Real-world evidence (RWE) is gaining a foothold as an important part...
19 September 2022 | By Mary Ellen Schneider PHOENIX, AZ – DARWIN EU, the Data Analysis and Real World Interrogation Network formed by the European Medicines Agency (EMA), is taking its...
To help better track submissions that include real-world data (RWD) and real-world evidence (RWE), the US Food and Drug Administration (FDA) is asking drug and biologics sponsors to indicate the...
To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission...
Executive summary The proposed European Health Data Space (EHDS) is not a mere regulation, it is a vision for the future of health and care for Europe. More effective use...
Research will advance data movement and analysis, as well as develop tools for automating workflows to aid in decision support. 31-Aug-2022 1:25 PM EDT, by Department of Energy, Office of Science favorite_border...
Real World Evidence (RWE) refers to scientific evidence generated from observational data collected during routine clinical care. Following the NICE methods review, the latest NICE Health Technology Evaluation Manual formalises the acceptability...
Komodo Deepens Its Commitment To Illuminate Critical Insights for Public Health and Industry Leaders to Better Address Gaps in Care for Colorectal Cancer Community July 25, 2022 07:15 AM Eastern...
EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA)....