Processing joint FDA and EMA voluntary genomic data submissions within the framework of the confidentiality arrangement - Scientific guideline

This document explains how the U.S. Food and Drug Administration and the European Medicines Agency will process requests for joint FDA-EMA voluntary genomic data submission (VGDS) briefing meetings.

Keywords: Joint FDA-EMA voluntary genomic data submission (VGDS)

Current version

Guiding principles: Processing joint Food and Drug Administration / European Medicines Agency voluntary genomic data submissions (VGDSs) within the framework of the confidentiality arrangement