News from the healthcare data industry
1. Scope This document provides an introduction to the MHRA’s real-world data (RWD) guideline series, and points to consider when evaluating whether a RWD source is of sufficient quality for the...
1. Overview This guideline is aimed at sponsors who are planning to conduct a randomised, controlled clinical trial primarily using real-world data (RWD) sources to support a regulatory decision relating to...
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for two...
TUCSON, Ariz., Dec. 1, 2021 — Critical Path Institute’s (C-Path) International Neonatal Consortium (INC) today announced a seminal data-sharing collaboration with the Eunice Kennedy Shriver National Institute of Child Health and...
Last week Datavant submitted comments on the recently issued FDA’s guidance that helped to clarify how real world data could be made “fit for purpose” in regulatory decision-making. In our response, we celebrated and...
BARCELONA, Spain, Dec. 1, 2021 /PRNewswire/ — The European Medicines Agency (EMA) has selected Aetion for a four-year term to support the agency’s Quality, Efficacy, and Safety Studies on Medicines. Aetion will...
In the move towards value-based care, digitally maturing healthcare systems can integrate AI to generate high quality data to personalise and integrate care, and even predict and prevent disease.By: December...
30-11-2021 The US Food and Drug Administration (FDA) has issued a draft guidance for drugmakers relating to the use of real-world evidence (RWE). In the guidance, titled Real-World Data: Assessing Registries...
Source: http://wam.ae/en/details/1395302997705 A declaration of collaboration between both entities was signed by Dr. Jamal Al Kaabi, Undersecretary of the Department of Health – Abu Dhabi, and Dr. Mohamed ElShaarawy, General...
Highlights Many new data sources have emerged in response to the increasing demand for real-world evidence to support healthcare decisionmaking in China. Nevertheless, public information regarding these data sources is...