News from the healthcare data industry
Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could benefit from Lynparza in combination with abiraterone September 03, 2024 01:00 PM Eastern...
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...
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...
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...
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...
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...
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)...
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...
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...
Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with...