Real-World Data Back in the Spotlight at FDA
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to...
Tag: FDA
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...
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)...
FDA releases final guidance on use of real-world data in regulatory submissions
The U.S. Food and Drug Administration (FDA) released its final guidance on the use of real-world data in regulatory submissions, detailing how drug companies should assess data from electronic health records and...
FDA lends further support to rare diseases by launching innovation hub
Elizabeth S. Eaton Published: July 17, 2024 Ref: FDA The FDA launched its second initiative this year aimed at aiding the development of drugs for rare diseases. The agency’s new Innovation...
Truveta announces support for regulatory submissions to the FDA and global regulatory authorities
BELLEVUE, Wash., June 18, 2024 (GLOBE NEWSWIRE) — Today, Truveta announced regulatory and audit capabilities to support its customers for real-world evidence (RWE) submissions to the Food and Drug Administration...
COTA Announces Extended Collaboration with FDA to Advance the Use of Real-World-Data in Cancer Research
May 22, 2024 09:00 AM Eastern Daylight Time NEW YORK–(BUSINESS WIRE)–Today, COTA announced an extension of its research collaboration with the U.S. Food and Drug Administration’s (FDA) Oncology Center of...
Aster Insights Announces Research Partnership with FDA to Study the Effects of Patient Demographics on Diagnostic Indicators Used for Checkpoint Inhibitor Therapy
Collaboration will focus on optimizing detection of biomarkers in diverse populations of patients with cancer and the development of novel research algorithms TAMPA, Fla., April 8, 2024 /PRNewswire/ — Aster Insights, the leading...
Navigating the FDA’s Guidance on Real-World Evidence: Insights, Expectations, and Future Trends in Clinical Trials
Transcript: Scott Swain, PhD, MPH: I’m Scott Swain, director of real-world evidence and regulatory science with Cardinal Health. What are your thoughts on the recently released FDA guidance concerning the use...
FDA Issues Draft Guidance for Using RWD in Medical Device Regulation
December 20, 2023 – On December 18, 2023, the United States Food and Drug Administration (FDA) published a draft guidance called “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” The document...