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Tag: FDA

Posted on December 5, 2023December 19, 2023 Collaborations Competitor News Data Partnership Government/Regulatory

Syapse and FDA Extend Collaboration to Advance the Use of Real-World Data (RWD) and Inform Regulatory Science in Oncology

SAN FRANCISCO, Dec. 05, 2023 (GLOBE NEWSWIRE) — Syapse®, a leading real-world evidence company dedicated to extinguishing the fear and burden of serious diseases by advancing real-world care, and the...

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 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 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...

Posted on August 31, 2023September 7, 2023 Government/Regulatory Industry News

FDA issues guidance on using real-world data for drug development

The FDA has released final draft recommendations for using real-world data and evidence in drug development. By Akosua Mireku The US Food and Drug Administration (FDA) has released a final draft...

Posted on April 10, 2023April 24, 2023 AI Collaborations Competitor News Government/Regulatory

Cerner Enviza Collaborates with FDA to Develop Innovative AI Tools for Drug Safety and Real-World Evidence Studies

FDA’s Sentinel Innovation Center chose Cerner Enviza and John Snow Labs for electronic health record and natural language processing expertise AUSTIN, Texas, April 10, 2023 /PRNewswire/ — Cerner Enviza, an Oracle company, along with John Snow...

Posted on February 8, 2023February 13, 2023 Government/Regulatory Industry News

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

Docket Number:FDA-2022-D-2983 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence This guidance provides recommendations to sponsors and investigators considering the...

Posted on January 24, 2023January 30, 2023 Collaborations Competitor News Data Partnership Government/Regulatory

Aetion Collaborates With FDA to Explore Oncology RWD for Regulatory Science Research

Aetion and FDA will use the Aetion Evidence Platform® to study crucial oncology research questions to advance the mission of the Oncology Center of Excellence’s Scientific Collaborative NEW YORK, Jan. 24, 2023 /PRNewswire/...

Posted on December 15, 2022January 6, 2023 Government/Regulatory Industry News

Reagan-Udall Foundation for the FDA Launches Real-World Data Initiative to Address Disparities

Federally supported project will advance solutions on race and ethnicity data for research (December 15, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) is launching the Real-world Accelerator to Improve...

Posted on December 7, 2022December 12, 2022 Collaborations Competitor News COVID-19 Data Partnership Government/Regulatory

Aetion Furthers Collaboration with FDA on Real-World Data

Partnership leverages Aetion’s platform for analyzing real-world data to generate evidence and support regulatory decision-making NEW YORK, Dec. 7, 2022 /PRNewswire/ — Aetion, the global leader in real-world evidence (RWE) technology and analytics,...

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