Regulatory Focus™ > News Articles > RAPS News: FDA/EMEA Common Application for Orphan Medicinal Products

RAPS News: FDA/EMEA Common Application for Orphan Medicinal Products

Posted 01 February 2008 | By

On 8 November 2007, the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a Common Application for Orphan Medicinal Product Designation. The intent of the common application is to reduce the administrative burden on companies who wish to apply to orphan medicinal product designation in both the US and EU and thus, hopefully, to increase the number of products available to treat rare or "orphan" diseases in both jurisdictions.

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