EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA meetings
EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings
The European Commission (EC), the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have agreed to a procedure for joint FDA EMEA briefing meetings with sponsors following voluntary submission of genomic data. The procedure has been agreed to within the scope of the confidentiality arrangements between the EC/EMEA and the FDA and is based on prior experience with joint briefings.
Much of pharmacogenomic data are of an exploratory nature and not required to be submitted to health authorities in most cases. However, voluntary submissions of such data is encouraged as a means to ensure that regulatory authorities are familiar with the issues arising from the integration of pharmacogenomics in drug development and to ensure that industry has an opportunity to hear scientific perspectives from the regulatory authorities. These joint voluntary submissions are important for regulatory agencies to ensure that evolving policies are based on the best science, to help in the development of common approaches to genomics in drug development, and to facilitate the use of pharmacogenomic tests during global drug development.
Voluntary genomic data submission packages will be reviewed by the FDA's Interdisciplinary Pharmacogenomic Review Group (IPRG) and the EMEA Pharmacogenetics Working Party (PGWP). Contact information for submitting a request for a joint voluntary genomic data submission meeting can be found in the guiding principles document.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
