News from the healthcare data industry
BELLEVUE, Wash., June 18, 2024 (GLOBE NEWSWIRE) — Today, Truveta announced regulatory and audit capabilities to support its customers for real-world evidence (RWE) submissions to the Food and Drug Administration...
May 22, 2024 09:00 AM Eastern Daylight Time NEW YORK–(BUSINESS WIRE)–Today, COTA announced an extension of its research collaboration with the U.S. Food and Drug Administration’s (FDA) Oncology Center of...
The European Medicines Agency (EMA) is seeking feedback on non-interventional studies (NIS) that use real-world data (RWD) for regulatory purposes. In the draft reflection paper, EMA defines a NIS as...
Collaboration will focus on optimizing detection of biomarkers in diverse populations of patients with cancer and the development of novel research algorithms TAMPA, Fla., April 8, 2024 /PRNewswire/ — Aster Insights, the leading...
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to add ten new data partners in...
The Biden Cancer Moonshot aims to support and center patients and caregivers, and President Biden has made it clear that the American people deserve a health care system that they...
Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for medical devices requires changes to make...
Across federal agencies, diverse legacy approaches to data management, data interoperability, and data sharing have taken shape over decades, making it increasingly challenging to maximize the value of data even...
The US Food and Drug Administration (FDA) has presented case studies on the use of real-world evidence (RWE) to support device approvals, but there is little guidance provided by the...
Transcript: Scott Swain, PhD, MPH: I’m Scott Swain, director of real-world evidence and regulatory science with Cardinal Health. What are your thoughts on the recently released FDA guidance concerning the use...