Advancing Real-World Evidence Program
As announced in the Federal Register notice published on October 20, 2022, FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks to improve the quality and acceptability of...
Tag: FDA
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission...
FDA Commissioner Califf and the Potential of RWE in Clinical Trials
When Robert Califf became the new commissioner of the U.S. Food & Drug Administration, he did so with a plan to emphasize the use of real-world evidence (RWE) in Agency decisions....
Real-World Evidence: US FDA Urged To Leverage Prior Validation Work and Regulatory Experience
Executive Summary In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do...
Industry cites outdated standards as flaw in FDA’s real-world data draft guidance
Posted 11 February 2022 | By Joanne S. Eglovitch The US Food and Drug Administration (FDA) should adopt updated data standards that accommodate the “evolving and emerging” nature of real-world data...
CDER unveils 30 new planned guidance documents in 2022 agenda
Posted 07 February 2022 | By Jeff Craven About one-third of the guidance documents in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER)’s 2022 guidance...
RWE Alliance Submits Comments on FDA’s RWE Draft Guidance, Highlights Recommendations for Agency’s RWE Program and RWE Derived from EHR/Claims Data
January 24, 2022 04:12 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using...
FDA: The outlook for 2022
By Dr Nicola Davies Since 2020, the US Food and Drug Administration’s activities have centered around the response to the COVID-19 pandemic.1 The agency closed out 2021 with the approval...
C-Path and NICHD to Share Real-world Data to Advance Neonatal Drug Development
TUCSON, Ariz., Dec. 1, 2021 — Critical Path Institute’s (C-Path) International Neonatal Consortium (INC) today announced a seminal data-sharing collaboration with the Eunice Kennedy Shriver National Institute of Child Health and...
Datavant Supports FDA Guidance with a Privacy-first Approach to Using Real World Evidence for Regulatory Decision Making
Last week Datavant submitted comments on the recently issued FDA’s guidance that helped to clarify how real world data could be made “fit for purpose” in regulatory decision-making. In our response, we celebrated and...