FDAnews Drug Daily Bulletin

The FDA should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, drug industry insiders urge. The Biotechnology Industry Organization (BIO) wants the agency to harmonize both the content and structure of drug applications so sponsors can submit the same dossier to several agencies. This would allow drugmakers and regulatory agencies to save resources.
Washington Drug Letter