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Category: Government/Regulatory

Posted on November 24, 2021January 3, 2022 Asia-Pacific Government/Regulatory Industry News International

Review of real world evidence and patient reported outcomes

We recently commissioned a review into our usage of real world evidence (RWE) and patient reported outcomes (PROs) in the regulation of medicines and medical devices. This considered stakeholders’ understanding...

Posted on November 19, 2021December 1, 2021 COVID-19 Government/Regulatory Industry News

Can Real-World Evidence Transform Healthcare? Recent FDA Activities Indicate Yes

By Stacy Cline Amin, Morrison & Foerster; former chief counsel of the FDA Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery...

Posted on November 5, 2021January 5, 2022 Government/Regulatory Industry News Oncology RWE Study

Clinical Cancer Research Publishes a Systematic Review of Regulatory Real-World Evidence in Successful Oncology Product Approvals

BOSTON, Nov. 5, 2021 /PRNewswire/ — Analysis Group, a global leader in health economics and outcomes research (HEOR) and regulatory epidemiology, today announced the publication of research examining the US Food and Drug...

Posted on October 28, 2021January 5, 2022 Clinical Trials Collaborations Competitor News Fundraising/IPO Government/Regulatory

Cardinal Health Awarded FDA Funding to Assess Real World Evidence Results Against Clinical Trials

DUBLIN, Ohio, Oct. 28, 2021 /PRNewswire/ — Cardinal Health (NYSE: CAH) announced today it has been awarded a $750,000 contract by the U.S. Food and Drug Administration (FDA) to implement an 18-month real world evidence (RWE)...

Posted on October 26, 2021January 5, 2022 Collaborations Government/Regulatory Industry News Product Updates

New Real-World Evidence Registry Launches

Newswise — Lawrenceville, NJ, USA—October 26, 2021—ISPOR—The Professional Society for Health Economics and Outcomes Research announced today that the Real-World Evidence Transparency Initiative has launched the Real-World Evidence Registry. The Real-World Evidence Transparency...

Posted on October 21, 2021January 5, 2022 Collaborations Competitor News COVID-19 Data Partnership Government/Regulatory

FDA selects Aetion Evidence Platform® to advance regulatory science and innovation

NEW YORK, NY, October 21, 2021 â€” Today, Aetion announces that it is expanding its relationship with the U.S. Food and Drug Administration (FDA) to use real-world evidence (RWE) to study...

Posted on October 7, 2021December 1, 2021 Collaborations Competitor News COVID-19 Government/Regulatory Oncology

HealthVerity awarded CDC contract for real-world healthcare data to advance COVID-19 response

PHILADELPHIA, Oct. 7, 2021 /PRNewswire/ — HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data, today announced that it has been awarded a contract with the Centers for Disease...

Posted on October 6, 2021December 1, 2021 Collaborations Competitor News Government/Regulatory

Aetion and NICE Announce Collaboration to Explore Use of Real-World Evidence for Comparative Effectiveness Studies to Inform Clinical Guidance

Collaboration will leverage the Aetion Evidence Platform® to study when and how RWE can support the agency’s decision-making NEW YORK, NY & MANCHESTER, ENGLAND, October 6, 2021 â€” Aetion today announced a collaboration...

Posted on October 4, 2021December 1, 2021 Collaborations COVID-19 Government/Regulatory Oncology

NIH Continues Collaboration With Palantir Technologies to Support COVID-19 Research

October 04, 2021 06:59 AM Eastern Daylight Time DENVER–(BUSINESS WIRE)–Palantir Technologies Inc. (NYSE:PLTR), a leading builder of operating systems for the modern enterprise, announced today the National Institutes of Health’s...

Posted on October 1, 2021December 1, 2021 Government/Regulatory Industry News

FDA, Sponsors Advance Reliance on Real-World Data & Evidence

October 1, 2021 Jill Wechsler, Pharm Exec’s Washington Correspondent Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into...

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