Single submission of orphan drug designation annual report for both FDA and EMA
Posted by: SomaNews on: 28 Feb, 2010
Single submission of orphan drug designation annual report for both FDA and EMA
In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union.
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