FDA and EMA Agree to Accept a Single Orphan Drug Designation Annual Report (EMA press release, 26 February 2010)

26 Feb 2010


In recognition of World Rare Disease Day (the last day of February), the US Food and Drug Administration and European Medicines Agency have agreed to jointly accept a single annual report for drugs that have obtained orphan drug designation. The decision should streamline the development of drugs for rare diseases.

EMA press release (pdf)


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