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Tag: FDA

Posted on November 30, 2021December 1, 2021 Government/Regulatory

FDA issues new draft guidance on real-world data

30-11-2021 The US Food and Drug Administration (FDA) has issued a draft guidance for drugmakers relating to the use of real-world evidence (RWE). In the guidance, titled Real-World Data: Assessing Registries...

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 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 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 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...

Posted on September 16, 2021January 5, 2022 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

Download Guidance here: https://www.fda.gov/media/152503/download

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