EU, EMEA and FDA Agree on Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings
News Jun 06, 2006
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.
Schizophrenics' Blood Contains RNA From More MicrobesNews
The blood of schizophrenia patients features genetic material from more types of microorganisms than that of people without the debilitating mental illness, research at Oregon State University has found. What’s not known is whether that’s a cause or effect of the severe, chronic condition that strikes about one person in 100.READ MORE
Faulty Gene Leads to Alcohol-Induced Heart FailureNews
A faulty gene interacts with alcohol to accelerate heart failure in susceptible patients, a study suggests. This dangerous interaction can occur even when only moderate amounts of alcohol have been consumed.READ MORE