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...
Category: 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...
Your health records are coming to new apps. Here’s why
Key Points The eponymous sign outside Epic headquarters in Verona, Wisconsin. Source: Yiem via Wikipedia CC It’s about to get a lot easier for patients in the U.S. to access...
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...
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...
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...
EMA shares draft paper on non-interventional studies using RWD
The European Medicines Agency (EMA) is seeking feedback on non-interventional studies (NIS) that use real-world data (RWD) for regulatory purposes. In the draft reflection paper, EMA defines a NIS as...
DARWIN EU® continues expanding its capacity to deliver real-world data studies
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to add ten new data partners in...