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Category: Government/Regulatory

Posted on July 22, 2022July 24, 2022 Europe Government/Regulatory Industry News International

EMA joins regulatory coalition in calling for RWE to be integrated into regulatory decisions

As more and more biotechs are looking into the potential applications of using real-world evidence in regulatory submissions, the European Medicines Agency is calling for more widespread adoption. EMA endorsed...

Posted on July 19, 2022July 24, 2022 Government/Regulatory Industry News

Registries for Regulatory Decision-Making: Comparing EMA and FDA Guidance on Real-World Evidence

The use of registries as part of real-world evidence is critical for the clinical and regulatory development of medicines. Read this blog post to understand from our regulatory affairs managers...

Posted on July 12, 2022July 15, 2022 Europe Government/Regulatory Industry News International

EU DARWIN Project To Catalog Real-World Data Sources

Executive Summary The latest meeting of the DARWIN EU advisory board heard about moves to increase the number of RWD sources that can be analyzed and to improve the efficiency...

Posted on July 1, 2022July 4, 2022 Europe Government/Regulatory Industry News International Oncology

Major EU Research Project Targets Personalized Medicine, Unlocking Of Health Data

Executive Summary Neurodegenerative and cardiovascular diseases, along with cancer and early feasibility studies, are among the topics to be addressed by consortia interested in taking part in the EU’s latest...

Posted on June 29, 2022July 4, 2022 Europe Government/Regulatory Industry News International

England: HTA Body NICE Makes Big RWE Push

Executive Summary England’s health technology appraisal institute, NICE, has published its real-world evidence framework.NICE LAUNCHES RWE FRAMEWORK With its newly published real-world evidence (RWE) framework, NICE, England’s health technology appraisal...

Posted on June 29, 2022July 4, 2022 Government/Regulatory Industry News

How The Cures Act Information Blocking Rule Could Impact Research

Health care providers collect vast amounts of electronic health information (EHI) that hold enormous potential for advancing science. However, that potential has been limited by a lack of incentives, imperatives, and...

Posted on June 28, 2022July 4, 2022 Europe Government/Regulatory Industry News International

EMA, HTA Bodies & Payers Explore Common Ground On Use Of RWE

Executive Summary A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment...

Posted on June 27, 2022July 4, 2022 Government/Regulatory Industry News

A new phase of the Cancer Moonshot to end cancer as we know it

Improved screening, novel therapies and a focus on health equity can reduce cancer mortality by 50% in the next 25 years, but these must be underpinned by an investment in...

Posted on June 24, 2022June 24, 2022 Europe Government/Regulatory Industry News International

NICE: Real-World Evidence Revolution Will Drive UK’s Health Care Innovation

Decision-makers will have more data on which to judge the value of innovative medtech and healthtech products Read More: https://medtech.pharmaintelligence.informa.com/MT145554/NICE-Real-World-Evidence-Revolution-Will-Drive-UKs-Health-Care-Innovation

Posted on June 15, 2022June 16, 2022 Government/Regulatory Industry News

Collins, Kaine Bill to Improve Accelerated Approval Process for Lifesaving Drugs Advances in Senate

The bipartisan bill would reform the FDA pathway that provides early access to treatments for patients with serious and life-threatening conditions Washington, D.C.—U.S. Senators Susan Collins (R-ME) and Tim Kaine...

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