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Category: Industry News

Posted on February 4, 2022February 7, 2022 Clinical Trials Industry News

The Journey from Hesitancy to a Reliance on Real World Data

Karen Ooms, Executive Vice President and Head of Statistics, Quanticate 02.04.22Today more and more pharmaceutical companies are turning to real-world evidence (RWE) to understand the real-life effectiveness of their drug...

Posted on February 2, 2022February 5, 2022 Government/Regulatory Industry News

United Kingdom: NICE changes its evaluation methods towards greater flexibility

Baker McKenzie United Kingdom February 2 2022 NICE has produced a single guidance development manual, which describes how NICE conducts itself with each step and stage in its evaluation (NICE’s processes) and...

Posted on February 1, 2022 Clinical Trials Industry News

Synthetic control arms in clinical trials: Making it happen

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. But what does it take to implement these...

Posted on January 28, 2022 Industry News

Unlocking Real-World Data Offers Real Benefits to Public Health

Published on 01/27/2022 By Matthew Franklin, Dan Howdon, Suzanne Mason, Tony Stone, Monica Jones The use of the terms “real-world data” and “real-world evidence” in the context of health decision-making has grown substantially in the last...

Posted on January 28, 2022 Government/Regulatory Industry News Partner and Collaborator News Pharma

Amgen, Regeneron and others seek more detail from FDA on real-world data plans

Zachary BrennanSenior Editor, Endpoint News Back in late September, the FDA released a long-awaited guidance on how the industry might use electronic health records (EHRs) or medical claims data in...

Posted on January 24, 2022January 25, 2022 Government/Regulatory Industry News

RWE Alliance Submits Comments on FDA’s RWE Draft Guidance, Highlights Recommendations for Agency’s RWE Program and RWE Derived from EHR/Claims Data

January 24, 2022 04:12 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using...

Posted on January 24, 2022January 25, 2022 Industry News

FDA: The outlook for 2022

By Dr Nicola Davies Since 2020, the US Food and Drug Administration’s activities have centered around the response to the COVID-19 pandemic.1 The agency closed out 2021 with the approval...

Posted on January 23, 2022October 4, 2022 Industry News Marketing Survey

Less selling, more science can best help doctors navigate complex new cancer treatments, report suggests

by Natalie Missakian | Jan 23, 2022 1:25pm The future of cancer drug marketing will be about helping oncologists understand the complexities of precision medicine and how new advances in targeted therapies can...

Posted on January 20, 2022January 25, 2022 Europe Government/Regulatory Industry News International

NICE signals commitment to greater flexibility in its evaluation of promising new health technologies and making patient access fairer

Changes to the way medicines and other health technologies are evaluated by NICE for use in the NHS were approved by its Board yesterday (19 January 2022). 20 January 2022...

Posted on January 18, 2022January 25, 2022 Industry News

Addressing 4 Common Roadblocks When Using RWD in Regulatory Submissions

January 18, 2022Scott Swain, PhD, MPH Since 2016, the 21st Century Cures Act has required the Food and Drug Administration (FDA) to consider the utility of any real-world evidence (RWE)...

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