Donna Young «U.S., EU Will Use Same Orphan Drug Application.». BioWorld News [Washington], 28-11-2007 [Consulta: 6 gener 2008]. «In an attempt to simplify the process for obtaining orphan status for medications targeting rare diseases, the FDA and the European Medicines Agency (EMA) have created a common application. ... U.S. and European regulators still will conduct independent reviews of application submissions to ensure the data submitted meet the legal and scientific requirements of their respective jurisdictions, the agencies said.»
