Government/Regulatory, Industry News

FDA official clarifies misconceptions around RWE in premarket submissions

Regulatory News | 05 August 2024 | Jeff Craven Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference. “[R]eal…

Government/Regulatory, Industry News

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Docket Number:FDA-2020-D-2307Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support…

Competitor News, Marketing, Product Updates, Use Case and Case Studies

EVERSANA Unveils TEDAVI, the Breakthrough Content Creation Hub to Transform Agency Marketing Models and Maximize Brand Impact

CHICAGO, Aug. 1, 2024 /PRNewswire/ — EVERSANA, a leading provider of global commercial services to the life sciences industry, today introduced TEDAVI, the pharmaceutical and life science industry’s premier content transformation hub built to streamline content production, enable personalization at scale and accelerate time-to-market for brand assets while ensuring compliance. Developed by the company’s…

Collaborations, Competitor News, Data Partnership

Verana Health and HealthVerity Partner to Advance Use of Real-World Evidence in Research

Data partnership initiative expands access to critical healthcare data in ophthalmology, urology and neurology San Francisco, CA., July 30, 2024 — Verana Health®, a digital health company dedicated to revolutionizing patient care and clinical research through real-world data (RWD), today announced a strategic partnership with HealthVerity, the leader in synchronizing transformational technologies and…

Europe, Government/Regulatory, Industry News, International

UK Data Sharing Network To Pilot A Common Framework For RWE Studies

Executive Summary A new UK network, led by an expert who has also worked on high-level EU data projects, has been established to test whether a common data model could help to facilitate real-world evidence studies by increasing the “usability” of data.Source: Shutterstock Health Data Research UK, the country’s national…

Collaborations, Competitor News

Datavant, Premier Inc, Privacy Analytics to Showcase Privacy Enhancing Technologies in Healthcare at Congressional Briefing

NEW YORK, July 29, 2024 /PRNewswire/ — Datavant, the leading health data platform company, is proud to announce its participation in the upcoming Congressional briefing on privacy enhancing technologies in healthcare. The event, hosted by the Healthcare Trust Institute (HTI), will take place on July 30, 2024, from 12 PM to 1 PM. This briefing…

Collaborations, Competitor News, Data Partnership

Lynx.MD and Schweiger Dermatology Forge Alliance to Advance Dermatology Research with Real-World Data

Partnership Expands Lynx.MD Dominance in Specialty Practice Areas Lynx.MD, a leading healthcare data intelligence platform, announced a new partnership with Schweiger Dermatology Group, one of the nation’s top dermatology practices. This collaboration will establish a comprehensive real-world data (RWD) repository specifically focused on accelerating advancements in dermatology research and patient…

Government/Regulatory, Industry News

FDA finalizes guidance on RWD from electronic health records

Regulatory News | 25 July 2024 | Ferdous Al-Faruque FDA headquarters in White Oak, MD. (Source: Ferdous Al-Faruque) The US Food and Drug Administration (FDA) has finalized its guidance on evaluating real-world data (RWD) from electronic health records (EHR). The final guidance offers additional clarification on selecting study variables and validation and includes recommendations…