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Category: Government/Regulatory

Posted on October 30, 2023November 14, 2023 Competitor News Government/Regulatory

Health Gorilla Achieves Designation as a Qualified Health Information Organization (QHIO) in the California Health and Human Services Data Exchange Framework

Mountain View, CA, Oct. 30, 2023 (GLOBE NEWSWIRE) — Health Gorilla, a privacy-focused Health Information Network and interoperability solution provider, announced today that it has achieved designation as a Qualified Health...

Posted on October 19, 2023October 20, 2023 Government/Regulatory Industry News

When can real-world data generate real-world evidence?

Key Points In accordance with the 21st Century Cures Act of 2016 (Cures Act),1 the Food and Drug Administration (FDA or the Agency) launched a program for evaluating the use of...

Posted on October 9, 2023 Competitor News Government/Regulatory

U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Lilly’s Retevmo® (selpercatinib) for Certain Patients with Solid Tumors

Foundation Medicine’s tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with solid tumors with RET gene fusions who may benefit from treatment with Retevmo October 09,...

Posted on October 5, 2023October 9, 2023 Competitor News Government/Regulatory

Komodo Health Awarded CMS Innovator’s License, Enabling Integration of Critical Payer Data To Enhance Customers’ Understanding of Patient Experience and Needs

As the company continues to invest in the quality of data in its Healthcare Map, the coveted Innovator’s License from the Centers for Medicare & Medicaid Services (CMS) will unlock...

Posted on October 2, 2023October 9, 2023 Collaborations Competitor News Government/Regulatory

FDA and Flatiron Health’s collaborative study to evaluate real-world outcomes in patients with organ impairment

October 2, 2023 In today’s rapidly evolving landscape of accelerated drug development, reliance solely on data derived from traditional randomized control trials (RCTs) is shifting toward a combination of RCT...

Posted on September 25, 2023October 9, 2023 Europe Government/Regulatory Industry News International

European Data-Sharing Rules Could Make a Reality of RWD and RWE

Legislative efforts seek a common framework in accessing and applying real-world data and evidence in clinical studies. Discussions on current European legislative initiatives edge forward in drug approval and the...

Posted on September 22, 2023September 25, 2023 Government/Regulatory Industry News Synthetic Data

Agencies Explore Policy Barriers, Synthetic Data to Maintain Health Care Privacy

Policy changes and synthetic data could play a key role in eliminating risks while improving data access and security. Nikki Henderson Fri, 09/22/2023 – 17:00 Federal leaders from NIH, VA,...

Posted on September 22, 2023September 25, 2023 Government/Regulatory Industry News

FDA’s Califf: Expect to see more RWE-based regulatory decisions

WASHINGTON – Use of electronic health records (EHR) to collect real-world evidence (RWE) that can then be used to expand a product’s indication is going to become more common, according...

Posted on September 18, 2023September 25, 2023 Fundraising/IPO Government/Regulatory Industry News

Cancer Moonshot Initiative Receives $240 Million Boost

On September 13, during a meeting of the Cancer Cabinet, President Joe Biden and First Lady Dr. Jill Biden announced a $240 million investment to accelerate advances in cancer-related projects,...

Posted on September 6, 2023September 7, 2023 Collaborations Competitor News Data Partnership Government/Regulatory

Flatiron Health Enters New Five-Year Research Collaboration with FDA on Real-World Data

September 06, 2023 09:00 AM Eastern Daylight Time NEW YORK–(BUSINESS WIRE)–Flatiron Health today announced its renewed collaboration with the Oncology Center of Excellence (OCE) of the United States Food and...

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