Author Topic: International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report  (Read 85 times)

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International Collaboration:  FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report
27 February 2010, 6:23 am

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.

Source: Food and Drug Administration--Press Releases


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