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Category: Industry News

Posted on March 5, 2024March 18, 2024 Government/Regulatory Industry News

Improving Cancer Care Through Better Electronic Health Records: Voluntary Commitments and Call to Action

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...

Posted on February 26, 2024March 18, 2024 Government/Regulatory Industry News

Industry calls for changes in FDA’s RWE guidance for devices

Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for medical devices requires changes to make...

Posted on February 9, 2024 Blogs/Publications Industry News Marketing

National Hospital Flash Report: January 2024

Following hospitals’ worst financial year since the beginning of the COVID-19 pandemic, 2023 presented a more promising trend for hospitals and health systems with general improvement across operational and financial...

Posted on February 9, 2024 Competitor News Government/Regulatory Industry News

Data Modernization: How Federal Agencies Are Learning from Commercial Peers

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...

Posted on February 5, 2024February 9, 2024 Europe Government/Regulatory Industry News International

More guidance needed to use RWE to support device approvals in EU

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...

Posted on February 2, 2024February 5, 2024 Government/Regulatory Industry News

Navigating the FDA’s Guidance on Real-World Evidence: Insights, Expectations, and Future Trends in Clinical Trials

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...

Posted on November 10, 2023November 14, 2023 Industry News

Focusing in on real-world evidence and its capabilities

he deeper you look and the more you magnify, the richer the details that emerge. Generate more pixels and you get a cleaner, sharper view, yet in standard clinical trials...

Posted on November 8, 2023November 14, 2023 Government/Regulatory Industry News

ONC COMMITS TO SUPPORT FOR FHIR IN UPDATED TEFCA STANDARDS

The agency has released several adjustments to the first draft of the interoperability guidelines and expects to unveil version 2.0 next spring KEY TAKEAWAYS TEFCA, authorized by Congress through the...

Posted on November 6, 2023November 14, 2023 Industry News

How to unlock the power of real-world data in clinical research

It’s now more important than ever for healthcare organizations to ensure information quality and integrity in today’s data-driven healthcare landscape. Nov 06 23 Through the utilization of real-world data (RWD)...

Posted on October 26, 2023November 14, 2023 Industry News

How to leverage real-world data for better patient care

Real-world data (RWD) creates exciting new opportunities to improve patient safety. This data helps to bridge the gap between research and healthcare practice, allowing life sciences companies and care providers...

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